Manufacturer and brand owner in Qian'An, Hebei, China. 5 device types, 2 products catalogued, 3 clearances.
Innovita (Tangshan) Biological Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Reagent, Coronavirus Serological, Visual, Pregnancy Hcg, Prescription Use and 3 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
FDA registration record for Innovita (Tangshan) Biological Technology Co., Ltd. | Registered name | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013332582 |
| FEI number | 3013332582 |
| DUNS | 554456128 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Innovita (Tangshan) Biological Technology Co., Ltd. | Chinese legal name | 英诺特（唐山）生物技术有限公司 |
| Unified social credit code | 91130283568909612G |
| Source | NMPA UDI database |
Location
Address of Innovita (Tangshan) Biological Technology Co., Ltd. | City | Qian’An |
| Province | Hebei |
| Address | No.699 Juxin Street,High-tech Industrial Development Zone |
| Postal code | 064400 |
| Country | China |
From the Company
Published by the company on its own website, not by the FDA.
Information published by Innovita (Tangshan) Biological Technology Co., Ltd. | Founded | 2006 |
| Factory area | 160,000 sq meters (Tangshan facility) |
| Main products | Respiratory diagnostics, Digestive virus detection, Prenatal/postnatal screening, Hepatitis testing |
| Certifications | CE, ISO 13485 |
| Export markets | International markets |
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.