MARK ENTERPRISES

FDA Device Registration & Listing · Nashik Maharashtra, IN · Registration 3002821232

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002821232
FEI Number
3002821232
Entity Name
MARK ENTERPRISES
City/State/Country
Nashik Maharashtra, IN
Establishment Address
SHED NO.1, PLOT NO. 93/2, STREET NO.17, MIDC SATPUR, Nashik Maharashtra 422007, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Mark Enterprises (Owner Number: 10082069)
Owner / Operator Contact Address
Plot No. 30, Swapnmangal Aanadiketan, Gail No. 4/1, Shalejaval Kale Nagar, Satpur MIDC, Nashik-422007,, Nashik, IN-MH 422007, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ultra sonic Cleaner- MEUC-01, MEUC-02, MEUC-3 FACE MASK-N95-KN95-ANTI POLLUTION & DUST MASK CPAP Machine- MPAP-01,MPAP-04,MPAP-03,MPAP-04 CPAP/ BIPAP (MPAP-01, MPAP-02, MPAP-03, MPAP-04) BIPAP Machine- MBIP-01,MBIP-02,MBIP-03,MBIP-04, Needle Destroyer (MND-01,MND-02,MND-03,MND-04) TMT Machine (MTMT-01, MTMT-02, MTMT-03) ECG Machine (MECG-01, MECG-02, MECG-03, MECG-04) CTG Machine (MCTG-01, MCTG-02, MCTG-03, MCTG-04) BP Apparatus (MEBP-01,MEBP-02,MEBP-03) BP Apparatus- MEBP-01, MEBP-02, MEBP-03,MEBP-04 Defibrillator (MEDBR-01, MEDBR-02, MEDBR-03, MEDBR-04) Defibrillator- MDFLTR-01, MDFLTR-02, MDFLTR-03, MDFLTR-04, MDFLTR-05 Cell Counter/ Hematology Analyzer (MHA-01,MHA-02,MHA-03,MHA-04,MHA-05) DENTAL CHAIRS & DENTAL OPERATING ACCESSORIES Dental (Chair (Automatic/Manual) / Bed / Operating Accessories)- MEDE-01, MEDE-02, MEDE-03, MEDE-04 Anaesthesia Machine/ Work Station- MEAW-01, MEAW-02, MEAW-03, MEAW-04 Advanced Polarization- MMB-01, MMB-02, MMB-03, MMB-04 Microscope/ Compound, ENT, Ophthalmic, Binocular, Trinocular, Stereo, OT Pendant (Operating Theatre) Pendant (MEOP-01, MEOP-02,MEOP-03,MEOP-04) Volumetric Infusion Pump (MVIP-01, MVIP-02, MVIP-03, MVIP-04) Thermometer/ Stem Alcohol Thermometer (MSAT-01,MSAT-02,MSAT-03,MSAT-04) Audiometer- MEAM-01,MEAM-02,MEAM-03 BLOOD COLLECTION MONITOR, DEVICE, BLOOD MIXING AND BLOOD WEIGHING Electro Surgical unit- MESU-01, MESU-02, MESU-03, MESU-04, MESU-05 Electrosurgical Device (MESD-01,MESD-02,MESD-03,MESD-04) Refrigerated Centrifuge- MRC-01, MRC-02, MRC-03, MRC-04, MRC-05, Microfuge: MMCF-02 Refrigerated Centrifuge (MRC-01, MRC-02, MRC-03, MRC-04, MRC-05), Gel Card Centrifuge (MGC-01,MGC-02,MGC-03), LAB CENTRIFUGE- (MLC-01, MLC-02, MLC-03, MLC-04) Non-Refrigerated Centrifuge/Gel Card Lab Centrifuge/Research Centrifuge- Non-Refrigerated Centrifufge Machnie (MNRC-01,MNRC-02,MNRC-03,MNRC-04,MNRC-05) Microfuge: MMCF-04 Microfuge: MMCF-01 Microfuge: MMCF-03 MNRC-01, MNRC-02, MNRC-03, MNRC-04, MNRC-05, MNRC-06 ELISA READER - (MER-01,MER-02, MER-03, MER-04) PROGRAMABLE REMOTE TEMPERATURE AND EVENT MONITORING SYSTEM (MTEMS-01,MTEMS-02,MTEMS-03) Elisa Reader / Washer (Reader and Washer)- MER-01, MER-02, MER-03, MER-04 X-Ray View Box (MXVB-01,MXVB-02,MXVB-03) Medical Hospital Lamps (MHL-01, MHL-02, MHL-03, MHL-04, MHL-05, MHL-06, MHL-07) DATA LOGGER (MTM-01,MTM-02,MTM-03) PRTEM System/ Data Logger- MTEMS-01, MTEMS-02, MTEMS-03, MTEMS-04, MTEMS-05 Ice Lined Refrigerator- MHMCEILRV004, Blood Collection Monitor (Bio-mixer)- MBCM-03, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-16, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-18, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-4, MDFU-5, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MHMCEULTV003, Solar Refrigerator cum Freezer- MSRCF-01,MSRCF-02, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-30, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MHMCEULTV004, Blood Collection Tube- MBCT-02, Blood Collection Monitor (Bio-mixer)- MBCM-04, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-19, Blood Collection Monitor (Bio-mixer)- MHBBEBCMB002, Blood Collection Tube- MBCT-03, Shock Freezer/Blast Freezer/ Contact Shock Freezer-MHBBEBLFR004, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-15, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-27, Ice Lined Refrigerator- MILR-03, MILR-04, Blood Donation Van- MBV-03, Blood Collection Monitor (Bio-mixer)- MBCM-02, Solar Refrigerator cum Freezer- MSRCF-07, Plasma Expressor/Extractor (Automatic/Manual)- MPE-01, Solar Refrigerator cum Freezer- MSRF-03, MSRF-04, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MDFU-1, MDFU-2, Ice Lined Refrigerator- MHMCEILRV001, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-21, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MHMCEULTV001, Blood Bank Refrigerator-MHBBEBBTF004, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-28, Blood Collection Monitor (Bio-mixer)- MHBBEBCMB001, Blood Collection Tube- MBCT-04, Blood Bank Refrigerator-MBBR-07, Shock Freezer/Blast Freezer/ Contact Shock Freezer-MHBBEBLFR002, Solar Refrigerator cum Freezer- MSRF-07 Plasma Expressor/Extractor (Automatic/Manual)- MPE-03, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MHAO MDFU-12 Plasma Expressor/Extractor (Automatic/Manual)- MPE-04, Ice Lined Refrigerator- MHMCEILRV003, Blood Donation Van- MBV-04, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-17, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-6, MDFU-7, Blood Collection Monitor (Bio-mixer)- MBCM-01, Stabilizer (1 phase, 3 phase)- MESCVS-01, MESCVS-02, Blood Bank Refrigerator-MBBR-03, MBBR-04, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-24, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-26, Solar Refrigerator cum Freezer- MSRF-01,MSRF-02, Plasma Expressor/Extractor (Automatic/Manual)- MPE-02, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-22, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-25, Ice Lined Refrigerator- MILR-05, MILR-06, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-20, Blood Collection Tube- MBCT-01, Blood Bank Refrigerator-MHBBEBBTF002, Stabilizer (1 phase, 3 phase)- MESCVS-03, MESCVS-04, Ice Lined Refrigerator- MILR-01, MILR-02, Blood Collection Monitor (Bio-mixer)- MHBBEBCMB004, Blood Donation Van- MBV-01, Blood Donation Van- MBV-02, Solar Refrigerator cum Freezer- MSRCF-03, MSRCF-04, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MHMCEULTV002, Blood Bank Refrigerator-MBBR-05, MBBR-06, Solar Refrigerator cum Freezer- MSRF-05, MSRF-06, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-14, Blood Collection Monitor (Bio-mixer)- MHBBEBCMB003, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-13, Blood Bank Refrigerator-MBBR-01, MBBR-02, Stabilizer (1 phase, 3 phase)- MESCVS-05, MESCVS-06 Shock Freezer/Blast Freezer/ Contact Shock Freezer-MHBBEBLFR003, Ice Lined Refrigerator- MHMCEILRV002, Shock Freezer/Blast Freezer/ Contact Shock Freezer-MHBBEBLFR001, Blood Collection Tube- MBCT-05, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFH-01, MDFU-3, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-23, Blood Bank Refrigerator-MHBBEBBTF003, Solar Refrigerator cum Freezer- MSRCF-05, MSRCF-06, Blood Bank Refrigerator-MHBBEBBTF001, Vaccine / Deep Freezer (-15°C to -25°C, -10°C to -40°C)-MDFU-29, Blood Collection Monitor (Bio-mixer)- MBCM-05, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-10, MDFU-11 Ice Lined Refrigerator- MILR-07, Ultra Low Temperature Deep Freezer (-50°C to -86°C)- MDFU-8, MDFU-9, Suction Machine (MESM-01, MESM-02, MESM-03, MESM-04) Anetsthesia Workstation (MEAW-01, MEAW-01, MEAW-01, MEAW-04) Refrigerated Water Bath-MHBBERRBT003, MHBBERRBT004 Hot Air Oven-MHAO-05 Cryoprecipitate/Water Bath-MHBBECRBT003, MHBBECRBT004, Serological Water Bath-MSWB-03, MSWB-04, Hot Air Oven-MHAO-03, MHAO-04, Cryoprecipitate/Water Bath-MCB-01, MCB-02, Plasma Thawing Bath-MPTB-03, MPTB-04, Serological Water Bath-MSWB-01, MSWB-02, Plasma Thawing Bath-MPTB-01, MPTB-02, Cryoprecipitate/Water Bath-MHBBECRBT001, MHBBECRBT002, Hot Air Oven-MHAO-01, MHAO-02, Refrigerated Water Bath-MRWB-03, MRWB-04, Cryoprecipitate/Water Bath-MCB-05, Refrigerated Water Bath-MHBBERRBT001, MHBBERRBT002, Serological Water Bath-MSWB-05 Cryoprecipitate/Water Bath-MCB-03, MCB-04, Plasma Thawing Bath-MHBBEPLTB003, MHBBEPLTB004, Refrigerated Water Bath-MRWB-01, MRWB-02, Plasma Thawing Bath-MHBBEPLTB001, MHBBEPLTB002, Ophthalmoscope- MEOS-01,MEOS-02,MEOS-03 Hemoglobino Strips (MHS-01,MHS-02,MHS-03) ETO Sterilizer / ETO Sterilizer- METO-01, METO-02, METO-03, METO-04, METO-05, Autoclave (Vertical, Horizontal, Table-Top) - MACL-01, MACL-02, MACL-03, MACL-04, Dressing Drum (MEDD-01, MEDD-02, MEDD-03) Medical washer-disinfector- MMWU-01,MMWU-02,MMWU-03 Sterilizer- MACL-01, MACL-02, MACL-03, MACL-04, Electroencephalograph (EEG)- MEEG-01,MEEG-02,MEEG-03 Lyophilizer: MLZR-01 Lyophilizer: MLZR-03 Lyophilizer: MLZR-04 Lyophilizer: MLZR-02 Weighing Scale- MESWS-01, MESWS-02, MESWS-03, MESWS-04 Donor Weiging Scale (MEWS-01, MEWS-02, MEWS-03, MEWS-04 ) Laminar Air Flow/Biosafety Cabinet Class II (MLAF-01, MLAF-02, MLAF-03, MLAF-04, MLAF-05,MLAF-06,) MHBBEPLIA002, MHBBEPLIA003, MHBBEPLIA004 Platelet Incubator with Agitator- MPAI-01, MPAI-02, MPAI-3, MPAI-04, MPAI-05, MHBBEPLIA001, Nebulizer- MNBL-01, MNBL-02, MNBL-03, MNBL-04,MNBL-05 VDRL Shaker (MVDRL-01, MVDRL-02, MVDRL-03,MVDRL-04) Urine Analyzer- MEUA-01, MEUA-02, MEUA-03, MEUA-04, C-Arm Machine- MCAM-01, MCAM-02, MCAM-03, MCAM-04, Digital Aanalytical Balance (MDAB-01,MDAB-02,MDAB-03,MDAB-04) Blood Grouping & Crossmatching Analyzer (MBGCA-01,MBGCA-02,MBGCA-03,MBGCA-04) Infant/Baby Incubator (MBIN-01, MBIN-02, MBIN-03, MBIN-04) Ultrasonic Cleaner (MEUC-01,MEUC-02,MEUC-03) Voltage Stabilizer (MESCVS-01, MESCVS-02, MESCVS-03, MESCVS-04, MESCVS-05) Automated Blood Component Separator (MBCE-01,MBCE-02,MBCE-03,MBCE-04,MBCE-05) Blood Irradiators (MBIR-01, MBIR-02, MBIR-03, MBIR-04) Ultrasound Machines (MUSG-01, MUSG-02, MUSG-03, MUSG-04) Active Cold Box (MACB-01, MACB-02, MACB-03, MACB-04, MACB-05, MACB-06) Orbital Shaking Incubator (MOIN-01, MOIN-02, MOIN-03, MOIN-04, MOIN-05) Rotary Flask Shaker (MRFS-01,MRFS-02,MRFS-03,MRFS-04) Cool Pod (MCP-01, MCP-02, MCP-03, MCP-04, MCP-05, MCP-06, MCP-07) Semi Automatic Biochemistry Analyzer (MBCA-01, MBCA-02,MBCA-03,MBCA-04) Colorimeter (MECM-01,MECM-02,MECM-03) Sterilizers (MEST-01,MEST-02,MEST-03,MEST-04) Cautery Machine (MCTM-01, MCTM-02, MCTM-03, MCTM-04) Blood Warmer- MBWMR-01, MBWMR-02, MBWMR-03, MBWMR-04, MBWMR-05, Baby Incubator - MBIN-01,MBIN-02, MBIN-03,MBIN-04, PRT System (MPRT-01, MPRT-02, MPRT-03, MPRT-04) Electrolyte Analyzer (MEA-01, MEA-02, MEA-03) Humidity Chamber/ Environment chamber- MEHC-01, MEHC-02, MEHC-03, MEHC-04, MEHC-05, AHU System (MAHU-01,MAHU-02,MAHU-03,MAHU-04) Fluid Warmer (MFW-01, MFW-02, MFW-03) Bio Safety Cabinet (MBSC-01, MBSC-02, MBSC-03, MBSC-04, MBSC-05, MBSC-06) Automated Blood Collection System (MBCS-01,MBCS-02,MBCS-03,MBCS-04,MBCS-05) Boyle's Machine (MEBM-01,MEBM-02,MEBM-03) Rolling Hypothermia Treatment Carts (MRTC-01,MRTC-02, MRTC-03,MRTC-04) , Digital Analytical Balance- MDAB-01, MDAB-02, MDAB-03, MDAB-04, Ultrasound Machine- MUSG-01, MUSG-02, MUSG-03, MUSG-04, MMDS-06,MMDS-07,MMDS-08,MMDS-09,MMDS-10,MMDS-11,MMDS-12,MMDS-13, Colorimeter/Photometric Immunoassay Analyzer- MECM-01,MECM-02,MECM-03, , Blood Tube Mixer/Roller Mixer- MERM-01, MERM-02, MERM-03, MERM-04, Boyle’s Machine- MEBM-01, MEBM-02, MEBM-03, Visi Cooler (MVIC-01, MVIC-02, MVIC-03, MVIC-04, MVIC-05, MVIC-06, MVIC-07) Hemoglobin strip MHS-01,MHS-02,MHS-03, VDRL Shaker/Rotary Flash Shaker- MVDRL-01, MVDRL-02, MVDRL-03, MVDRL-04, Hemoglobin Analyzer- MEHA-01, MEHA-02, MEHA-03, MEHA-04, Blood Component Separator/ Blood Cell Seperator- MBCE-01, MBCE-02, MBCE-03, MBCE-04, Apheresis Machine- MAPH-01, MAPH-02, MAPH-03, MAPH-04, MAPH-05, Carbondioxide Incubator- MCOI-01, MCOI-02, MCOI-03, MCOI-04, MCOI-05, Hemoglobin Analyzer (MEHA-01,MEHA-02,MEHA-03,MEHA-04) Cautery Machine- MCTM-01, MCTM-02, MCTM-03, MCTM-04, Dialysis Machine-MDMC-01, MDMC-02, MDMC-03, MDMC-04, Bacteriological Incubator/ Laboratory Incubator - MBLI-01, MBLI-02, MBLI-03, MBLI-04, C-Arm machine (MCAM-01,MCAM-02,MCAM-03,MCAM-04) Automated Platelet Collection Systems (MPCS-01, MPCS-02, MPCS-03, MPCS-04) Diagnostic Spirometer- MEDS-01,MEDS-02,MEDS-03, Biosafety Cabinet- MBSC-01, MBSC-02, MBSC-03, MBSC-04, MBSC-05, MBSC-06, Microdrill-MMDS-01,MMDS-02,MMDS-03,MMDS-04,MMDS-05, Magnetic Stirrers(MEMS-01,MEMS-02,MEMS-03,MEMS-04) Biochemistry Analyzer - MEBA-01, MEBA-02, MEBA-03, MEBA-04, Cell Washer- MECW-01, MECW-02, MECW-03, MECW-04, Electrolyte Analyser/Ion-Selective Analyzer- MEA-01, MEA-02, MEA-03, Automated Immunoassay System(MIS-01,MIS-02,MIS-03,MIS-04 ) Endoscopy Machine (MEDM-01, MEDM-02, MEDM-03) Mobile Refrigerator Storage Cold Drawers (MMSCD-01,MMSCD-02,MMSCD-03,MMSCD-04,MMSCD-05) Gel Card Incubator- MINC-01, MINC-02, MINC-03, Organ Preservative Solution-MOPS-01, MOPS-02, MOPS-03, MOPS-04 Biochemistry Analyzer (MEBA-01, MEBA-02, MEBA-03, MEBA-04) Bacteriological Incubator (MBI-01,MBI-02,MBI-03,MBI-04,MBI-05,MBI-06) Double Pan Balance/Centrifuge Bucket Equalizer- MDPB-01, MDPB-02, MDPB-03, MDPB-04, Blood Warmer (MBW-01, MBW-02, MBW-03, MBW-04) Fumigator (MEFG-01, MEFG-02,MEFG-03,MEFG-04) Cold Box (MCBX-01,MCBX-02,MCBX-03,MCBX-04,MCBX-05,MCBX-06 ) Foot Step (MEFS-01, MEFS-02,MEFS-03) Roller Mixer (MERM-01, MERM-02, MERM-03, MERM-04) Ambu Bag- MEAB-01, MEAB-02, MEAB-03, MEAB-04, Endoscopy Machine-MEDM-01, MEDM-02, MEDM-03, MEDM-04, BOD Incubator- MBODI-01, MBODI-02, MBODI-03, MBODI-04,MBODI-05, Apheresis Machine (MIS-01, MIS-02, MIS-03, MIS-04) HVAC System (MHAVC-01,MHAVC-02,MHAVC-03,MHAVC-04) Ambu Bag (MEAB-01, MEAB-02, MEAB-03) Fogger Machine (MFGM-01, MFGM-02, MFGM-03, MFGM-04 ) Colony Counter: MCCR-02 Colony Counter: MCCR-04 Colony Counter: MCCR-03 Colony Counter: MCCR-01 MICROSCOPE BINOCULAR (MMB-01, MMB-02,MMB-03,MMB-04) Patient Monitor (MEPM-01, MEPM-02, MEPM-03, MEPM-04) Modular Multipara Monitor (MMM-01, MMM-02, MMM-03, MMM-04, MMM-05) Electronic oesophageal stethoscope- MEES-01,MEES-02,MEES-03 Operation Table - MHB-01, MHB-02, MHB-03, MHB-04, Medical/Hospital/Baby Furniture- MEBF-01, MEBF-02, MEBF-03, MEBF-04, MEBF-05, Paediatric Bed/ LDR or Delivery Bed- MPB-01, MPB-02, MPB-03, Hospital Trolley (MHTR-01,MHTR-02,MHTR-03,MHTR-04,MHTR-05,MHTR-06,MHTR-07) Plain Bed (MEPB-01, MEPB-02, MEPB-03) Electric beds (MEB-01,MEB-02,MEB-03) Stretcher (MSTR-01,MSTR-02,MSTR-03,MSTR-04) Baby furniture (MEBF-01, MEBF-02, MEBF-03,MEBF-04,MEBF-05) ICU Bed/ Operation Bed- MICU-01, MICU-02, MICU-03, Hospital Bed/ Ward Plain Bed/ Electric Bed/ Hospital Beds (MHB-01, MHB-02,MHB-03,MHB-04,MHB-05,MHB-06,MHB-07) Bedside Screen (MBS-01, MBS-02,MBS-03,MBS-04), Lockers (ML-01,ML-02,ML-03) LDR Bed (MLDR-01, MLDR-02, MLDR-03) Ward plain bed (MWPB-01,MWPB-02,MWPB-03), Semi fowler bed (MSB-01,MSB-02,MSB-03) ICU bed (MICU-01,MICU-02,MICU-03), Pediatric bed (MPB-01,MPB-02,MPB-03) Patient Bed Semi-Fowler, Fowler- MSB-01, MSB-02, MSB-03, Bedside Screen- MBS-01, MBS-02, MBS-03, MBS-04, Bedside Locker, ML-01, ML-02, ML-03, Bed Fowler bed (MEFB-01, MEFB-02, MEFB-03) IV Rod (MEIV-01, MEIV-02, MEIV-03) Blood Donation Camp Cot (MDCC-01, MDCC-02, MDCC-03, MDCC-04) DONOR COUCH,Blood Donor Couch (MBDC-01,MBDC-02,MBDC-03,MBDC-04,MBDC-05) Blood Donor Chair/Couch/Camp Cot- MBDC-01, MBDC-02, MBDC-03, MBDC-04, MBDC-05, Bed- MSNBREGBED09, MSNBREGBED10, MSNBREGBED11, MSNBREGBED12, MSNBREGBED13, MSNBREGBED14, MSNBREGBED15, MSNBREGBED16, MSREGULSBD31 MDR N95-KN95-ANTI POLLUTION & DUST MASK, Clothing, Sanitary Napkin FACE SHIELDS; FACEMASKS; SAFETY GLASSES; SURGICAL MASKS Personal Protective Equipment-PPE Kit (MPPE-01, MPPE-02, MPPE-03) PPE Kit- MPPE-01, MPPE-02, MPPE-03, Face Mask- MFM-01, MFM-02, MFM-03, MFM-04, MFM-05 PH meter- MPM-01, MPM-02, MPM-03, MPM-04 PH Meter (MPM-01,MPM-02) BLOOD COLLECTION MONITOR (MBCM-01,MBCM-02,MBCM-03,MBCM-04,MBCM-05) Fetal Monitor- MEFM-01, MEFM-02, MEFM-03, MEFM-04 Fetal Monitor (MEFM-01,MEFM-02,MEFM-03) Fetal Doppler (MEFD-01,MEFD-02,MEFD-03) Fetal Doppler- MEPD-01, MEPD-02, MEPD-03, MEPD-04, Micropipette (MMPP-01, MMPP-02,MMPP-03,MMPP-04,MMPP-05) Pipette/Micropipette-MMPP-01, MMPP-02, MMPP-03 Digital Hemoglobinometer (MDHM-01,MDHM-02,MDHM-03,MDHM-04) MHC-08, MHC-09, MHC-10, MHC-11, Examination Table- MET-01, MET-02, MET-03, MET-04, MET-05 Hospital/Operation Chair-MHC-01, MHC-02, MHC-03, MHC-04, MHC-05, MHC-06, MHC-07, X-Ray Machine- MXVB-01, MXVB-02, MXVB-03, MXVB-04 Sterile Connecting Device (MSCD-01,MSCD-02,MSCD-03) DI-ELECTRICAL TUBE SEALER Blood Bag Tube Sealer (Dielectric Tube Sealer)-MBBTS-01, MBBTS-02, MHBBEBTSB003, MHBBEBTSB004, Blood Bag Stripper- MBTS-01, MBTS-02 ,MBTS-03, MBTS-04 MBBTS-03, MBBTS-04, MBBTS-05, MHBBEBTSB001, MHBBEBTSB002, FULLY AUTOMATIC ADULT & PREDIATRIC VENTILATOR (MVTR-01,MVTR-02,MVTR-03)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2026-01-09
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2021-06-11
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2025-03-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2024-09-12
IXO Synchronizer, Ecg / Respirator, Radiographic Radiology Class 1 892.1970 2025-03-13
JJN Apparatus, Electrophoresis, For Clinical Use Clinical Chemistry Class 1 862.2485 2025-03-13
PMK Cpr Aid Device Without Feedback Cardiovascular Class 1 870.5210 2025-03-13
JCN Control, Cell Counter, Normal And Abnormal Hematology Class 2 864.8625 2024-09-12
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2021-06-11
BYW Device, Rebreathing Anesthesiology Class 1 868.5675 2026-01-09
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2026-01-09
FSY Light, Surgical, Ceiling Mounted General, Plastic Surgery Class 2 878.4580 2025-03-13
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2025-03-13
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 2021-06-11
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2026-01-09
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2021-06-24
NWI Electrosurgical Electrode Kit Gastroenterology, Urology Class 2 876.4300 2025-03-13
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2021-06-11
PSP Intracranial Pressure & Temperature Monitoring Kit Neurology Class 2 882.1620 2024-02-20
KSY Boxes, View, Blood Grouping Hematology Class 1 864.9185 2025-03-13
FQP Lamp, Operating-Room General, Plastic Surgery Class 2 878.4580 2024-09-12
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2024-02-20
KSQ Device, Blood Mixing And Blood Weighing Hematology Class 1 864.9195 2021-06-11
OJR Vacuum Powered Body Fluid Collection Kit General, Plastic Surgery Class 2 878.4780 2025-03-13
OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric) Anesthesiology Class 1 868.5240 2025-03-13
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2021-06-11
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2026-01-09
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2024-09-12
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2025-03-13
GWR Generator, Electroencephalograph Test Signal Neurology Class 1 882.1430 2026-01-09
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2026-05-18
FRW Scale, Patient General Hospital Class 1 880.2720 2024-09-12
QKH Assisted Reproduction Laminar Flow Workstation Obstetrics/Gynecology Class 2 884.6120 2021-06-11
KSH Chamber, Environmental For The Storage Of Platelet Concentrate Hematology Class 2 864.9575 2026-01-09
OGG Humidifier Nebulizer Kit Anesthesiology Class 2 868.5450 2026-01-09
JRQ Shaker/Stirrer Clinical Chemistry Class 1 862.2050 2024-02-20
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2024-09-12
KZC Manual Colony Counter Microbiology Class 1 866.2180 2026-05-18
PUE Biomicroscope, Slit-Lamp, Ac-Powered, Exempt Ophthalmic Class 2 886.1850 2024-02-20
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2025-03-13
BZW Stethoscope, Esophageal Anesthesiology Class 1 868.1910 2026-01-09
FNL Bed, Ac-Powered Adjustable Hospital General Hospital Class 2 880.5100 2021-06-11
FML Chair, Blood Donor General Hospital Class 1 880.6140 2021-06-11
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2021-06-11
JQY Ph Meter Clinical Chemistry Class 1 862.2050 2024-02-20
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2024-02-20
OHC Obstetrical Vacuum Delivery Kit Obstetrics/Gynecology Class 2 884.4340 2025-03-13
JRC Micro Pipette Clinical Chemistry Class 1 862.2050 2025-03-13
GGM Control, Hemoglobin Hematology Class 2 864.8625 2024-09-12
FRK Chair, Examination And Treatment General Hospital Class 1 880.6140 2026-01-09
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2026-01-09
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2024-02-20
GHY Hematocrit, Tube, Rack, Sealer, Holder Hematology Class 2 864.6400 2021-06-11
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2021-06-11

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

Mark Enterprises
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K102092 Prestige Ameritech PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES 2010-10-06
K780666 Castle Co. DAYSTAR SELECTRA & SELECTRA/ORBITER 1978-04-27
K780270 Maico Hearing Instruments, Inc. COMPUTER AUDIOMETER - MA26 1978-02-27
K923074 Life-Tech Intl., Inc. DANPLEX SCREENING AUDIOMETER 1992-09-23
K781173 Instrumentation Laboratory CO COMPUTER INTERFACE IL 814 1978-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Similar Registrations

Registration Number Establishment Name Location
3008993611 P & T MEDICAL Ningbo Zhejiang, CN
2518690 Keystone Industries - Delran Delran, NJ, US
1000355982 ARMSTRONG MANUFACTURING INCORPORATED Mississauga Ontario, CA
3007697908 Novapharm Research Australia Pty Ltd Rosebery New South Wales, AU
2183301 PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002821232. Last updated year: 2026. Please use registration number 3002821232 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.