Data / Medical devices / Taiwan / China Surgical Dressings Center Co.,ltd
China Surgical Dressings Center Co.,ltd: FDA-registered device maker in CHANGHWA CITY, FU-TIEN LI Changhua, Taiwan, 1 510(k) clearance
China Surgical Dressings Center Co.,ltd is registered with the FDA (registration 9613778) in CHANGHWA CITY, FU-TIEN LI Changhua, Taiwan. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613778
- FEI number
- 3002806752
- Address
- No. 21 Lane 424, Sec. 6 Chang Nan Rd., CHANGHWA CITY, FU-TIEN LI Changhua, Taiwan, 50080
- Owner or operator
- CHINA SURGICAL DRESSINGS CENTER CO.,LTD (9014393)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 29, 1999
- Registered through
- 2026
- Brand names listed
- CSD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2005 | K050689 | SURGICAL FACE MASK | FXX | Substantially Equivalent | China Surgical Dressings Center Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Dressing, Compression
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Mask, Surgical
- All makers of Bandage, Elastic
- All makers of Tourniquet, Nonpneumatic
Updated October 26, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.