Data / Medical devices / China / Shanghai Gangkai Purifying Products Co., Ltd.
Shanghai Gangkai Purifying Products Co., Ltd.: FDA-registered device maker in Songjiang Shanghai, China, 1 510(k) clearance
Shanghai Gangkai Purifying Products Co., Ltd. is registered with the FDA (registration 3004168184) in Songjiang Shanghai, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004168184
- Address
- Bldg No. 5, 683 Wenbing Road Xinbang, Songjiang Shanghai, China, 201605
- Owner or operator
- SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. (9026663)
- Roles
- Manufacturer
- First device listed
- March 31, 2008
- Registered through
- 2026
- Brand names listed
- GANGKAI, GIKO
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Respirator, Surgical | MSH | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 8, 2006 | K063334 | SHANGHAI GANGHAI MODEL GIKO 1400 | MSH | Substantially Equivalent | Shanghai Gangkai Purifying Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 8, 2006. 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.