Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042989733

FEI Number

3042989733

Entity Name

MARKEN HEALTHTECH LIMITED

City/State/Country

NASHIK Maharashtra, IN

Establishment Address

PLOT NO.93/1, STREET NO.17, MIDC, NASHIK Maharashtra 422007, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MARKEN HEALTHTECH LIMITED (Owner Number: 10094906)

Owner / Operator Contact Address

PLOT NO.93/1, STREET NO.17, MIDC, NASHIK, IN-MH 422007, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Volumetric Infusion Pump- MVIP-01, MVIP-02, MVIP-03, MVIP-04 ECG Machine- MECG-01, MECG-02, MECG-03,MECG-04, CTG Machine- MCTG-01, MCTG-02, MCTG-03, MCTG-04 PPE Kit- MPPE-01, MPPE-02, MPPE-03, Face Mask- MFM-01, MFM-02, MFM-03, MFM-04, MFM-05 Sperm/Semen Warmer- MSW-01, MSW-02, MSW-03 Pulse Oximeter- MEPO-01, MEPO-02, MEPO-03, MEPO-04 Hospital Lamp- MHL-01, MHL-02, MHL-03, MHL-04, MHL-05, MHL-06, MHL-07 Microscope/ Compound, ENT, Ophthalmic, Binocular, Trinocular, Stereo, Advanced Polarization- MMB-01, MMB-02, MMB-03, MMB-04 MHA-01, MHA-02, MHA-03, MHA-04, MHA-05 Cell Counter / Hematology Analyzer/ 3 Part,4 Part, 6 Part- Electronic oesophageal stethoscope- MEES-01,MEES-02,MEES-03 Oxygen Concentrator- MEOX-01,MEOX-02,MEOX-03 Nebulizer- MNBL-01, MNBL-02, MNBL-03, MNBL-04,MNBL-05 MHC-06, MHC-07, MHC-08, MHC-09, MHC-10, MHC-11, Hospital/Operation Chair-MHC-01, MHC-02, MHC-03, MHC-04, MHC-05, Examination Table- MET-01, MET-02, MET-03, MET-04, MET-05 Blood Donor Chair/Couch/Camp Cot- MBDC-01, MBDC-02, MBDC-03, MBDC-04, MBDC-05, Bed- MSNBREGBED13, MSNBREGBED14, Bed- MSNBREGBED09, MSNBREGBED10, MSNBREGBED11, MSNBREGBED12, Blood Donor Chair/Couch/Camp Cot- MBDC-01, Blood Donor Chair/Couch/Camp Cot- MBDC-03, Bed- MSNBREGBED11, MSNBREGBED12, Blood Donor Chair/Couch/Camp Cot- MBDC-05, Blood Donor Chair/Couch/Camp Cot- MBDC-04, Bed- MSNBREGBED15, MSREGULSBD31-MDR Bed- MSNBREGBED09, MSNBREGBED10 Blood Donor Chair/Couch/Camp Cot- MBDC-02, MSNBREGBED13, MSNBREGBED14, MSNBREGBED15, MSNBREGBED16, MSREGULSBD31,MDR Anaesthesia Machine/ Work Station- MEAW-01, MEAW-02, MEAW-03, MEAW-04 Fetal Doppler- MEPD-01, MEPD-02, MEPD-03, MEPD-04, Fetal Monitor- MEFM-01, MEFM-02, MEF03, MEFM-04 Audiometer- MEAM-01,MEAM-02,MEAM-03 Over Bed Table- MOBT-01, MOBT-02, MOBT-03, MOBT-04, MOBT-05, Patient Shifting Roller- MPSR-01, MPSR-02, MPSR-03, MPSR-04, MPSR-05, Hospital Trolley- MHTR-01, MHTR-02, MHTR-03, MHTR-04, MHTR-05, MHTR-06, MHTR-07, MOTE-01, MOTE-02, MOTE-03, MOTM-01, MOTM-02, MTOM-03, Strecher- MSTCHR-01, MSTCHR-02, MSTCHR-03, MSTCHR-04, MSTCHR-05, Dressing Table- MSWDREGDRT16, MSWDREGDRT17, MSWDREGDRT18 OT Table: Hydraulic, Electric, Manual- MOTH-01,MOTH-02, MOTH-03, Emergency Recovery Trolly- MERT-01,MERT-02,MERT-03,MERT-04,MERT-05, Ophthalmoscope- MEOS-01,MEOS-02,MEOS-03 Sterile Connecting Device- MSCD-01, MSCD-02, MSCD-03 Serological Water Bath- MSWB-03, Refrigerated Water Bath-MHBBERRBT001, MHBBERRBT002, Serological Water Bath- MSWB-04, Plasma Thawing Bath-MHBBEPLTB003, MHBBEPLTB004 Cryoprecipitate/Water Bath-MCB-04, MCB-05, Serological Water Bath- MSWB-02, Cryoprecipitate/Water Bath-MHBBECRBT003, MHBBECRBT004 Refrigerated Water Bath-MHBBERRBT003, MHBBERRBT004 Serological Water Bath- MSWB-05, Refrigerated Water Bath-MRWB-01, MRWB-02, Serological Water Bath- MSWB-01, Cryoprecipitate/Water Bath-MHBBECRBT001, MHBBECRBT002, Plasma Thawing Bath-MPTB-03, MPTB-04, Plasma Thawing Bath-MHBBEPLTB001, MHBBEPLTB002, Cryoprecipitate/Water Bath-MCB-01, MCB-02, MCB-03, Refrigerated Water Bath-MRWB-03, MRWB-04, Plasma Thawing Bath-MPTB-01, MPTB-02, Elisa Reader / Washer (Reader and Washer)- MER-01, MER-02, MER-03, MER-04 Platelet Incubator with Agitator- MPAI-01, MPAI-02, MPAI-3, MPAI-04, MPAI-05, MHBBEPLIA001, MHBBEPLIA002, MHBBEPLIA003, MHBBEPLIA004 Crash Cart- MCC-01,MCC-02,MCC-03,MCC-04,MCC-05 Laminar Air Flow- MLAF-01, MLAF-02, MLAF-03, MLAF-04, MLAF-05, MLAF-06 Cold Box/Blood Transportation Box Ventilator/ Fully Automatic Adult & Paediatric Ventilator- MVTR-01, MVTR-02, MVTR-03 Needle Destroyer- MND-01, MND-02, MND-03, MND-04 PSA Oxygen Generator-MPOG-01, MPOG-02, MPOG-03, MPOG-04, MPOG-05, MPOG-06 Low Pressure Medical Oxygen Booster Pump- MLQP-01, MLQP -02, MLQP -03 MLQP -04, Bulk oxygen concentration system- MBOCS-01, MBOCS-02, MBOCS-03, MBOCS-04, MBOCS-05, Medical Deployable Oxygen Concentration System - MDOCS-01, MDOCS-02, MDOCS-03, MDOCS-04, High Pressure Medical Oxygen Booster Pump- MHQP-01, MHQP -02, MHQP -03, MHQP -04, HP-180, Containerized / Mobile Oxygen Generation Plant- MMOP-01, MMOP-02, MMOP-03, MMOP-04, MMOP-05, MMOP-06, Coagulometer-MCOG-01, MCOG-02, MCOG-03, MCOG-04, MCOG-05, MCOG-06 Medical gas pipeline system- MMGP-01, MMGP-02, MMGP-03, MMGP-04, MMGP-05, MMGP-06, MMGP-07, MMGP-08, BIPAP Machine- MBIP-01,MBIP-02,MBIP-03,MBIP-04, CPAP Machine- MPAP-01,MPAP-04,MPAP-03,MPAP-04 Ultra sonic Cleaner- MEUC-01, MEUC-02, MEUC-3 Hospital Bed/ Ward Plain Bed/ Electric Bed/ Operation Table-MHB-04, Bedside Screen- MBS-04, Bedside Locker, ML-02, Hospital Bed/ Ward Plain Bed/ Electric Bed/ Operation Table-MHB-02, ICU Bed/ Operation Bed- MICU-01, Hospital Bed/ Ward Plain Bed/ Electric Bed/ Operation Table-MHB-03, ICU Bed/ Operation Bed- MICU-02, Paediatric Bed/ LDR or Delivery Bed- MPB-03, Medical/Hospital/Baby Furniture- MEBF-02, Medical/Hospital/Baby Furniture- MEBF-05, Bedside Locker, ML-03, BED Patient Bed Semi-Fowler, Fowler- MSB-03, Bedside Screen- MBS-02, Medical/Hospital/Baby Furniture- MEBF-04, Patient Bed Semi-Fowler, Fowler- MSB-02, Paediatric Bed/ LDR or Delivery Bed- MPB-01, Hospital Bed/ Ward Plain Bed/ Electric Bed/ Operation Table-MHB-01, Medical/Hospital/Baby Furniture- MEBF-01, Medical/Hospital/Baby Furniture- MEBF-03, Bedside Locker, ML-01, Patient Bed Semi-Fowler, Fowler- MSB-01, Bedside Screen- MBS-03, ICU Bed/ Operation Bed- MICU-03, Paediatric Bed/ LDR or Delivery Bed- MPB-02, Bedside Screen- MBS-01, Pipette/Micropipette-MMPP-01, MMPP-02, MMPP-03 Defibrillator- MDFLTR-01, MDFLTR-02, MDFLTR-03, MDFLTR-04, MDFLTR-05 Weighing Scale- MESWS-01, MESWS-02, MESWS-03, MESWS-04 Blood Collection Monitor (Bio-mixer)-MBCM-01, MBCM-02, MBCM-03, Blood Collection Monitor (Bio-mixer)-MHBBEBCMB003, MHBBEBCMB004, Blood Donation Van- MBV-01, Blood Collection Monitor (Bio-mixer)-MHBBEBCMB001, MHBBEBCMB002, Blood Collection Tube- MBCT-03, Blood Donation Van- MBV-03, Plasma Expressor/Extractor (Automatic/Manual)- MPE-03, MPE-04, Blood Collection Tube- MBCT-05, Blood Collection Tube- MBCT-02, Blood Collection Monitor (Bio-mixer)-MBCM-04, MBCM-05, Blood Donation Van- MBV-04, Blood Collection Tube- MBCT-04, Plasma Expressor/Extractor (Automatic/Manual)- MPE-01, MPE-02 Blood Collection Tube- MBCT-01, Blood Donation Van- MBV-02, Thermometer (Stem Alcohol/ Mercury/ Digital)- MSAT-01, MSAT-02, MSAT-03, MSAT-04 Electro Surgical unit- MESU-01, MESU-02, MESU-03, MESU-04, MESU-05 Electroencephalograph (EEG)- MEEG-01,MEEG-02,MEEG-03 DVT Pump- MEDP-01, MEDP-02, MEDP-03, MEDP-04 Blood Bank Refrigerator-MHBBEBBTF002, Ice Lined Refrigerator-MILR-07, Solar Direct Drive Ice Lined Refrigerator-MSDDR-05, Walk-In Freezer- MWIF-01, Freez Dryer: Bench Top, Floor Base- MFDFB-02, Walk-In Freezer- MWIF-03, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-04, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-25, Stabilizer (1 phase, 3 phase)- MESCVS-04, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-06, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-01, Active Cold Box/Active Vaccine Transporter-MHMCEATCB001, Blood Bank Refrigerator-MHBBEBBTF004, ICE Pack/Water Pack- MIP-02, Solar Walk-In Freezer / Storage Unit- MSWF-02, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-05, Solar Refrigerator cum Freezer- MSRCF-04, MSRCF-05, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MHMCEULTV002, Solar Refrigerator cum Freezer- MSRCF-06, MSRCF-07 Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-12, MDFU-20, Fruit & Chiller- MFCH-05, RH View Box- MRHB-02, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-03, Solar Refrigerator cum Freezer- MSRF-05, MSRF-06, Refrigerator cum Freezer - MRCF-05, Active Cold Box/Active Vaccine Transporter-MACB-06, Refrigerator cum Freezer - MRCF-02, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-04, Frost Freezer- MEFF-03, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-05, Frost Freezer- MEFF-01, Condensing Unit- MECU-04, Cold Box/Blood Transportation Box- MCBX-04, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MHBBEBLFR002, Fruit & Chiller- MFCH-03, Refrigerator cum Freezer - MRCF-04, Solar Refrigerator cum Freezer- MSRF-01,MSRF-02, Active Cold Box/Active Vaccine Transporter-MHMCEATCB003, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-02, Solar Direct Drive Ice Lined Refrigerator-MSDDR-04, Blood Bank Refrigerator-MHBBEBBTF003, Solar Walk-In Freezer / Storage Unit- MSWF-04, Freez Dryer: Bench Top, Floor Base- MFDFB-04, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-08, Ice Lined Refrigerator-MILR-01, MILR-02, Walk-In Freezer- MWIF-02, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-05, Solar Walk-In Freezer / Storage Unit- MSWF-01, Stabilizer (1 phase, 3 phase)- MESCVS-05, Ice Lined Refrigerator-MHMCEILRV001,MHMCEILRV002, Refrigerator cum Freezer - MRCF-06, Stabilizer (1 phase, 3 phase)- MESCVS-03, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFH-01, MDFU-3, Ice Lined Refrigerator-MHMCEILRV003,MHMCEILRV004 Frost Freezer- MEFF-02, Condensing Unit- MECU-02, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-29, MDFU-30, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-23, MDFU-24, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-6, MDFU-7, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MHBBEBLFR004 Solar Walk-In Freezer / Storage Unit- MSWF-05, Active Cold Box/Active Vaccine Transporter-MACB-03, Condensing Unit- MECU-01, Freez Dryer: Bench Top, Floor Base- MFDBT-03, Coolpod- MCPD-05, Cold Box/Blood Transportation Box- MCBX-06, VISI-Cooler-MVIC-01, ICE Pack/Water Pack- MIP-04, MDR Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-10, MDFU-11, Solar Direct Drive Ice Lined Refrigerator-MSDDR-02, Fruit & Chiller- MFCH-04, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-01, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-05, Frost Freezer- MEFF-05, Active Cold Box/Active Vaccine Transporter-MACB-01, Freez Dryer: Bench Top, Floor Base- MFDBT-02, Condensing Unit- MECU-05, VISI-Cooler-MVIC-04, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-03, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-27, MDFU-28, Cold Box/Blood Transportation Box- MCBX-02, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-02, Walk-In Freezer- MWIF-06, Solar Direct Drive Ice Lined Refrigerator-MSDDR-07, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-21, MDFU-22, Walk-In Freezer- MWIF-05, Coolpod- MCPD-01, RH View Box- MRHB-01, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MHMCEULTV001, Ice Lined Refrigerator-MILR-03, MILR-04, Refrigerator cum Freezer - MRCF-07, Vaccine Carrier- MAVT-01, MAVT-02, Refrigerator cum Freezer - MRCF-01, Solar Refrigerator cum Freezer- MSRF-07, MSRCF-01, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MHMCEULTV003, Active Cold Box/Active Vaccine Transporter-MACB-02, VISI-Cooler-MVIC-03, Solar Direct Drive Ice Lined Refrigerator-MSDDR-06, Active Cold Box/Active Vaccine Transporter-MHMCEATCB004, Walk-In Freezer- MWIF-04, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-8, MDFU-9, Vaccine Carrier- MAVT-7, MAVT-08, Blood Bank Refrigerator-MBBR-07, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-02, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-06, Active Cold Box/Active Vaccine Transporter-MHMCEATCB002, VISI-Cooler-MVIC-02, Stabilizer (1 phase, 3 phase)- MESCVS-02, Active Cold Box/Active Vaccine Transporter-MACB-05, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-04, Cold Box/Blood Transportation Box- MCBX-03, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-19, MDFU-26, Blood Bank Refrigerator-MHBBEBBTF001, Blood Bank Refrigerator-MBBR-05, MBBR-06, Walk-In Cooler/Cold Room-MWIC-06, Walk-In Cooler/Cold Room-MWIC-01, ICE Pack/Water Pack- MIP-01, Walk-In Cooler/Cold Room-MWIC-02, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-02, Vaccine Carrier- MAVT-05, MAVT-06, Coolpod- MCPD-04, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MHBBEBLFR003, Blood Bank Refrigerator-MBBR-01, MBBR-02, Vaccine Carrier- MAVT-03, MAVT-04, Solar Walk-In Freezer / Storage Unit- MSWF-03, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-03, Stabilizer (1 phase, 3 phase)- MESCVS-01, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-01, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MDFU-1, MDFU-2, Freez Dryer: Bench Top, Floor Base- MFDFB-01, Active Cold Box/Active Vaccine Transporter-MACB-04, Solar Refrigerator cum Freezer- MSRF-03, MSRF-04, Freez Dryer: Bench Top, Floor Base- MFDBT-04, Fruit & Chiller- MFCH-01, ICE Pack/Water Pack- MIP-03, VISI-Cooler-MVIC-05, Solar Refrigerator cum Freezer- MSRCF-02, MSRCF-03, Shock Freezer/Blast Freezer/ Contact Shock Freezer- MHBBEBLFR001, Laboratory Refrigerator/Laboratory Deep Freezer/Reagent Refrigerator-MLR-04, Frost Freezer- MEFF-04, Stabilizer (1 phase, 3 phase)- MESCVS-06, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-06, Ice Lined Refrigerator-MILR-05, MILR-06, Freez Dryer: Bench Top, Floor Base- MFDFB-03, Condensing Unit- MECU-03, Walk-In Cooler/Cold Room-MWIC-05, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-17, MDFU-18, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-13, MDFU-14, Blood Bank Refrigerator-MBBR-03, MBBR-04, Coolpod- MCPD-03, Vaccine Carrier- MAVT-09 Cold Box/Blood Transportation Box- MCBX-05, Freez Dryer: Bench Top, Floor Base- MFDBT-01, Solar Walk-In Freezer / Storage Unit- MSWF-06, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-06, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MHMCEULTV004, Solar Walk-In Cooler /Refirgrated Storage Unit- MSWC-03, Solar Direct Drive Vaccine/Deep Freezer- MSDDF-01, Coolpod- MCPD-02, Refrigerator cum Freezer - MRCF-03, Refrigerated Truck/Insulated Vaccine Van/Vaccine Storage Van-MVAN-07, Solar Direct Drive Ice Lined Refrigerator-MSDDR-01, Cold Box/Blood Transportation Box- MCBX-01, Solar Direct Drive Ice Lined Refrigerator-MSDDR-03, Vaccine / Deep Freezer(-15°C to -25°C, -10°C to -40°C)-MDFU-15, MDFU-16, Ultra Low Temperature Deep Freezer (-50°C to -86°C)-MDFU-4, MDFU-5, Walk-In Cooler/Cold Room-MWIC-03, Fruit & Chiller- MFCH-02, Patient Monitor- MEPM-01, MEPM-02, MEPM-03, MEPM-04 Dental (Chair (Automatic/Manual) / Bed / Operating Accessories)- MEDE-01, MEDE-02, MEDE-03, MEDE-04

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2026-01-05
IXO	Synchronizer, Ecg / Respirator, Radiographic	Radiology	Class 1	892.1970	2026-01-05
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2026-01-05
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2026-01-05
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2026-01-05
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2026-01-05
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-05
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2026-01-05
BZW	Stethoscope, Esophageal	Anesthesiology	Class 1	868.1910	2026-01-05
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2026-01-05
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2026-01-05
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2026-01-05
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2026-01-05
BYW	Device, Rebreathing	Anesthesiology	Class 1	868.5675	2026-01-05
OHC	Obstetrical Vacuum Delivery Kit	Obstetrics/Gynecology	Class 2	884.4340	2026-01-05
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2026-01-05
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2026-01-05
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2026-01-05
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2026-01-05
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2026-01-05
PSP	Intracranial Pressure & Temperature Monitoring Kit	Neurology	Class 2	882.1620	2026-01-05
KSH	Chamber, Environmental For The Storage Of Platelet Concentrate	Hematology	Class 2	864.9575	2026-01-05
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2026-01-05
QKH	Assisted Reproduction Laminar Flow Workstation	Obstetrics/Gynecology	Class 2	884.6120	2026-01-05
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-05
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2026-01-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-01-05
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2026-01-22
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2026-01-05
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2026-01-05
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2026-01-05
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2026-01-05
PMK	Cpr Aid Device Without Feedback	Cardiovascular	Class 1	870.5210	2026-01-05
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2026-01-05
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	Class 1	864.9195	2026-01-05
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2026-01-05
NWI	Electrosurgical Electrode Kit	Gastroenterology, Urology	Class 2	876.4300	2026-01-05
GWR	Generator, Electroencephalograph Test Signal	Neurology	Class 1	882.1430	2026-01-05
PPH	Single Needle With Uni-Directional Pump Kit	Gastroenterology, Urology	Class 2	876.5820	2026-01-05
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2026-01-05
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2026-01-05
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2026-01-05

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

MARKEN HEALTHTECH LIMITED

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
K844444	Medical Parameters, Inc.	ESOPHAGEAL STETHOSCOPE	1985-01-10
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.

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Registration Number	Establishment Name	Location
3007329020	Cardinal Health 200, LLC	El Paso, TX, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN
3005595283	MEDLINE INDUSTRIES, LP - Laredo	LAREDO, TX, US
2029015	Sterigenics U.S., LLC	Ontario, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042989733. Last updated year: 2026. Please use registration number 3042989733 when referencing this establishment in official correspondence.