FDA Registration
Active
🇨🇳 China
GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.
Reg #: 3008559312
·
FEI: 3008559312
·
Expires 2026
Products
17
Proprietary Names
29
Establishment Types
4
Classifications
17
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Registration Details
- Registration Name
- GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.
- Registration Number
- 3008559312
- FEI Number
- 3008559312
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #12, Guancun Road, Jiangpu Street,Conghua
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222545
Owner / Operator
- Firm Name
- GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD
- Operator Number
- 10033567
- Address
- Intersection of Guancun Road, Jiangpu Street
- City
- Conghua
- State
- Guangdong
- Postal Code
- 510970
- Country
- CN
- Correspondent
- Yuehua Zhou
US Agent
- Business Name
- ABMED MEDICAL TECHNOLOGY INC
- Contact Name
- hui hong
- Address
- 800 East Wishkah Street, 1021 Aberdeen,
- City
- Aberdeen
- State
- WA
- ZIP
- 98520
- Country
- US
- [email protected]
- Phone
- 303 8000162
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2021-03-31 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-05-30 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2018-03-08 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2023-02-08 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2021-08-15 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2024-09-14 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2010-08-31 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2010-08-31 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2018-03-08 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2010-08-31 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2018-03-08 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2022-09-19 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-11-11 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2021-10-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-08-01 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2021-09-19 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2010-08-31 |
Proprietary Names
puyuan
IMPERTEC INDUSTRIES LTD Face Shield /Hood
puyuan face shield
surgical gown with hood
Disposable Medical Mask
PUYUAN
Surgical Gown
drap
Medline Surgical Face Mask and Medline Procedural Face Mask
Pu Yuan
Surgical hood
Emesis Basin
peel away lens
Protective Clothes (Protective Coveralls)
Thumbhook gown
level 2 surgical gown
operation room gown
coverall
disposable shorts
lab coat
scrub suit
apron
scrub
puyuan surgical packs
puyuan SDKP-0406 Laparoscopic abdominal surgery drap 254*193*315cm
gauze
tissue polly
pillow cover
bedsheet
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility