Shanghai Gangkai Purifying Products Co., Ltd.
Manufacturer and brand owner in Songjiang, Shanghai, China. 1 device type, 1 product catalogued, 1 clearance.
Shanghai Gangkai Purifying Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Respirator, Surgical. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
1device type
1product
1510(k) clearance
Registration
| Registered name | SHANGHAI GANGKAI PURIFYING PRODUCTS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004168184 |
| FEI number | 3004168184 |
| DUNS | 653746735 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 上海港凯净化制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Songjiang |
|---|---|
| Province | Shanghai |
| Address | Bldg No. 5, 683 Wenbing Road |
| Postal code | 201605 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Respirator, Surgical | Class 2 | Gangkai, Giko | 2008 | 118 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Particulate Respirator | MSH | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K063334 | 2006-12-08 | MSH | Abbreviated | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Factory area | 10000 m² |
| Main products | N95 masks, KN95 masks, P2 masks, FFP2/FFP3 masks, Medical masks |
| Certifications | NIOSH N95, GB2626-2019 KN95, AS/NZS 1716 P2, JIS T 8151 DS2, EN149 FFP2/FFP3, EN14683 Type IIR |
| Export markets | 60+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| BQ Plus Medical Co., Ltd. | 13 |
| Koo (Shanghai) Industries Co., Ltd. | 9 |
| KOO Medical Equipment (Shanghai) Co., Ltd. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.