Biohit Healthcare (Hefei) Co., Ltd.
Manufacturer and brand owner in Hefei, Anhui, China. 4 device types, 1 product catalogued.
Biohit Healthcare (Hefei) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Reagent, Coronavirus Serological, Covid-19 Multi-Analyte Antigen Device and 2 other device types. Its earliest product listing with the FDA dates from 2020.
4device types registered with the FDA
1product
Registration
| Registered name | BIOHIT HEALTHCARE (HEFEI) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016850770 |
| FEI number | 3016850770 |
| DUNS | 560014279 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 必欧瀚生物技术（合肥）有限公司 |
|---|---|
| Unified social credit code | 913401000822055000 |
| Source | NMPA UDI database |
Location
| City | Hefei |
|---|---|
| Province | Anhui |
| Address | Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang’an Road |
| Postal code | 230000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | Class N | 2020 | 12 | |
| Covid-19 Multi-Analyte Antigen Device | Class N | iHealth COVID-19/Flu A&B Rapid Test ( Model no. ICF-3000) | 2024 | 7 |
| Multi-Analyte Respiratory Virus Antigen Detection Test | Class 2 | iHealth Flu A&B/COVID-19 Rapid Test (model: ICF-7000), iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000) | 2026 | 4 |
| Reagent, Coronavirus Serological | Class N | SARS-CoV-2 IgM/IgG Antibody Test kit (Colloidal Gold Method) | 2020 | 12 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | SARS-CoV-2 tests, Antibody test kits, Gastric function tests, Pancreatic elastase assays, Antigen rapid tests |
| Certifications | Medical device manufacturing license, CE, SAHPRA, PEI approval |
| Export markets | Europe, South Africa, Germany |
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.
The manufacturer named here can complete this record.