Tianjin Zhengtian Medical Instrument Co., Ltd.
Registered establishment in Tianjin, China. 2 device types, 3 clearances.
Tianjin Zhengtian Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Unit, Heating, Powered, Accessory, Surgical Apparel. Its earliest product listing with the FDA dates from 2016.
2device types registered with the FDA
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010227982 |
| FEI number | 3010227982 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 天津正天医疗器械有限公司 |
|---|---|
| Unified social credit code | 91120110746653833R |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 318, Jingyi Road, Airport Economic Zone |
| Postal code | 300308 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable face mask | 2020 | 439 |
| Unit, Heating, Powered | Class 1 | Inion Thermo Waterbath | 2016 | 19 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K172267 | 2018-03-06 | NKB | Traditional | This company |
| K170056 | 2017-10-23 | HWC | Traditional | This company |
| K151508 | 2016-02-25 | HRS | Traditional | This company |
Nearby Manufacturers
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.
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