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SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref COIF-522
Identity
- Trade Name
- SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test EUDAMED
- Device Name
- SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test EUDAMED
- Model / Reference
- COIF-522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939663976800 EUDAMED06939663978323 EUDAMED
- Basic UDI-DI
- B-06939663976800 EUDAMEDB-06939663978323 EUDAMED
- EMDN Code
- W0105040619 EUDAMEDW0105041101 CORONAVIRUS AG EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test by Sejoy Biomedical Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06939663976800 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sejoy Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000008447
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED dd7f9d05-8be6-4029-9087-ee19e2153444 61 fields · synced Aug 3, 2026
- EUDAMED 802e70ad-5d71-4aca-9190-23abd2191042 61 fields · synced May 17, 2026