HEFEI MLUSH SANITARY PRODUCTS CO.,LTD

FDA Device Registration & Listing · Hefei Anhui, CN · Registration 3011526299

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
3011526299
FEI Number
3011526299
Entity Name
HEFEI MLUSH SANITARY PRODUCTS CO.,LTD
City/State/Country
Hefei Anhui, CN
Establishment Address
WEST WEIXI ROAD,YAOHAI INDUSTRIAL PARK, XINZHAN ZONE, Hefei Anhui 230011, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HEFEI MLUSH SANITARY PRODUCTS CO.,LTD (Owner Number: 10048649)
Owner / Operator Contact Address
WEST WEIXI ROAD,YAOHAI INDUSTRIAL PARK, XINZHAN ZONE, Hefei, CN-AH 230011, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Mixing Bowl surgical kit face shield underpad Blood lancet/Surgical blade Dental mirror Paper bag face mask sani tip Matrix Band Air Bed IV cannula alcohol pad Carbon Burs polish brush/cup/ prophy angle Doctor Cap/Bouffant Cap Massage Table Speed Handpiece barrier films intra oral tip Bib Holder surgical gown Nebulizor tube and mask,Dxygen mask Urine bag infusion set Mixing Tips, Pre Bent Needle Tips, Irrigation Needle, Dental Needle Cheek Retractor Urine cup, Dental cup bed sheet rolls,rest cover Dental Curved Syringes Non-woven Sponge saliva ejector,suction tips Dental Wedges cotton rolls dental needles /Irrigation Needle sealant cement IDEN tape Bandage dental kit COTTON SWAB Cotton buds Plastic Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2018-12-24
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2018-12-24
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2018-12-24
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) General Hospital Class 1 880.5630 2015-02-08
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2018-12-24
EIX Probe, Periodontic Dental Class 1 872.4565 2025-01-21
BTC Bag, Reservoir Anesthesiology Class 1 868.5320 2015-02-08
KHA Mask, Scavenging Anesthesiology Class 1 868.5590 2015-02-08
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2018-12-24
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2023-12-20
KIC Cushion, Flotation Physical Medicine Class 1 890.3175 2018-12-24
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2018-12-24
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2015-02-08
EJL Bur, Dental Dental Class 1 872.3240 2018-12-24
EHK Cup, Prophylaxis Dental Class 1 872.6290 2018-12-24
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2018-12-24
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2018-12-24
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2018-12-24
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2015-02-08
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2018-12-24
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2023-12-20
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2015-02-08
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2018-12-24
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2018-12-24
FOX Stand, Infusion General Hospital Class 1 880.6990 2018-12-24
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2026-01-06
EIG Retractor, All Types Dental Class 1 872.4565 2026-01-06
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2018-12-24
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2015-02-08
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2026-01-06
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2023-12-20
DYN Mouthpiece, Saliva Ejector Dental Class 1 872.6640 2015-02-08
DZN Instruments, Dental Hand Dental Class 1 872.4565 2018-12-24
EFN Cotton, Roll Dental Class 1 872.6050 2015-02-08
DZM Needle, Dental Dental Class 1 872.4730 2018-12-24
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2018-12-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2018-12-24
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2015-02-08
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2018-04-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-12-24

Official Correspondent

Sangdy Hu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

HEFEI MLUSH SANITARY PRODUCTS CO.,LTD
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
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K881862 Thermo Body Wrap Systems, Inc. THERMO-BODY-WRAP SYSTEM 1988-10-13
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K781592 Henry Schein, Inc. SURGICAL ASPIRATOR TIPS 1978-12-04
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number Establishment Name Location
1000264713 GUPPY PLASTIC INDUSTRIES (PENANG) SDN BHD Bukit Mertajam, Penang Pulau Pinang, MY
3040185149 PT FOOD PACKAGING JAYA Indramayu Jawa Barat, ID
3015916830 PACKERMAN SDN. BHD. Melaka, MY
3010692406 SHANGHAI GUANGSHENG INDUSTRIAL CO.,LTD. Shanghai, CN
1423537 Cardinal Health 200, LLC Waukegan, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011526299. Last updated year: 2026. Please use registration number 3011526299 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.