FDA Registration
Active
🇨🇳 China
WUHAN DYMEX HEALTHCARE CO., LTD.
Reg #: 3013006775
·
FEI: 3013006775
·
Expires 2026
Products
13
Proprietary Names
16
Establishment Types
3
Classifications
13
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Registration Details
- Registration Name
- WUHAN DYMEX HEALTHCARE CO., LTD.
- Registration Number
- 3013006775
- FEI Number
- 3013006775
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5,Dongfeng Avenue
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210433
Owner / Operator
- Firm Name
- WUHAN DYMEX HEALTHCARE CO., LTD.
- Operator Number
- 10050831
- Address
- Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5,Dongfeng Avenue
- City
- Wuhan
- State
- Hubei
- Postal Code
- 430000
- Country
- CN
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Kelly | FNW | Class 2 | General, Plastic Surgery | No | 2024-11-05 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2016-03-09 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2019-07-11 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2015-12-31 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2015-12-31 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2016-03-09 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2016-03-09 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2016-03-09 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2015-12-31 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2015-12-31 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2016-03-09 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2026-05-13 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2015-12-31 |
Proprietary Names
Disposable Sterile Radiation Protection Drape
GOWN, EXAMINATION
Surgical Face Mask
Bouffant cap
Isolation gown
DRESS, SURGICAL
Surgical Face Mask( Ear Loops and Tie-on)
BEDDING, DISPOSABLE, MEDICAL
COVER, SHOE, OPERATING-ROOM
Patient gown, Scrub suit
Shoe cover
surgical mask
Medical Face Mask
Drape, surgical
Sterile CT Surgical Drape
Lab coat, Lab jacket
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)