GFA Production Xiamen Co., Ltd.

FDA Device Registration & Listing · Tong An, Xiamen Fujian, CN · Registration 3008384335

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
3008384335
FEI Number
3008384335
Entity Name
GFA Production Xiamen Co., Ltd.
City/State/Country
Tong An, Xiamen Fujian, CN
Establishment Address
#20 HuLi Industrial Park, Mei Xi Dao, Tong An, Xiamen Fujian 361100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GFA Production Xiamen Co., Ltd. (Owner Number: 9073017)
Owner / Operator Contact Address
No. 20 Huli Industrial Park, Mei Xi Dao, Tong'an District, Xiamen, CN-FJ 361100, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Face Mask

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 2024-01-10
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2015-01-08
GEC Brush, Scrub, Operating-Room General, Plastic Surgery Class 1 878.4800 2015-01-08
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2025-09-29
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2010-05-09
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2026-03-23
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2026-03-23
HTD Forceps General, Plastic Surgery Class 1 878.4800 2010-05-09
FQM Bandage, Elastic General Hospital Class 1 880.5075 2010-05-06
LRR First Aid Kit With Drug Unknown Class N N/A 2011-04-13
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2012-03-07
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2020-06-03
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2026-03-23
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2013-07-10
LYZ Vinyl Patient Examination Glove General Hospital Class 1 880.6250 2024-08-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-06-03
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2016-12-28
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-09-29
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2010-05-23
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2010-05-06
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-08-21
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2010-05-06

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GFA Production Xiamen 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
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02
K945177 Eagle Health Supplies 4-O2 JR. (CPR MOUTH BARRIER) 1994-11-01
K052612 Shanghai Antares Industries, Inc. DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR 2005-11-22
K120584 Wealth on (Jiangsu) Co., Ltd. POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES 2012-07-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

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9710391 POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. XIAMEN Fujian, CN
9611500 Draegerwerk AG & Co. KGaA LUEBECK Schleswig-Holstein, DE
3005460813 TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD Taizhou Jiangsu, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008384335. Last updated year: 2026. Please use registration number 3008384335 when referencing this establishment in official correspondence.
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