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SARS-CoV-2 Antigen Rapid Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref INCP-502HRef INCP-502
Identity
- Trade Name
- SARS-CoV-2 Antigen Rapid Test EUDAMED
- Device Name
- SARS-CoV-2 Antigen Rapid Test EUDAMED
- Model / Reference
- INCP-502H EUDAMEDINCP-502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277517539 EUDAMED06970277517737 EUDAMED06936983139236 EUDAMED
- Basic UDI-DI
- B-06970277517539 EUDAMEDB-06970277517737 EUDAMEDB-06936983139236 EUDAMED
- EMDN Code
- W0105040619,W0105099099 EUDAMEDW0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDCroatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMEDEUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Antigen Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-06970277517539 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED f25bb88f-4daf-443f-af13-67ae0dbd1e9d 61 fields · synced Jul 9, 2026
- EUDAMED b9fe9e79-77f2-4999-beba-6d68e07caa77 61 fields · synced May 17, 2026
- EUDAMED 98a615c6-8c3d-4d8a-848e-5704cb0f406d 61 fields · synced May 19, 2026