FDA Registration
Active
🇹🇼 Taiwan
CHINA SURGICAL DRESSINGS CENTER CO.,LTD
Reg #: 9613778
·
FEI: 3002806752
·
Expires 2026
Products
8
Proprietary Names
1
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- CHINA SURGICAL DRESSINGS CENTER CO.,LTD
- Registration Number
- 9613778
- FEI Number
- 3002806752
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 21 Lane 424, Sec. 6 Chang Nan Rd.
- City
- CHANGHWA CITY, FU-TIEN LI Changhua
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K050689
Owner / Operator
- Firm Name
- CHINA SURGICAL DRESSINGS CENTER CO.,LTD
- Operator Number
- 9014393
- Address
- NO.21, LANE 424, SEC. 6, CHANGNAN ROAD, FU-TIEN LI
- City
- CHANGHUA CITY
- State
- TW-CHA
- Postal Code
- 50080
- Country
- TW
- Correspondent
- MICHAEL F.L. - CHANG
US Agent
- Business Name
- CSD US
- Contact Name
- Po Hung Chiang
- Address
- 306 Old Littleton Road, Harvard ,
- City
- Harvard
- State
- MA
- ZIP
- 01451
- Country
- US
- [email protected]
- Phone
- 781 8205651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2007-11-27 |
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2015-01-27 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2023-02-06 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-10-12 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2016-02-02 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1999-04-29 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 1999-04-29 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1999-04-29 |
Proprietary Names
CSD
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility