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COVID-19 Antigen Rapid Test Kit (Swab)
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref COV Ag-6012H
Identity
- Trade Name
- COVID-19 Antigen Rapid Test Kit (Swab) EUDAMED
- Device Name
- COVID-19 Antigen Rapid Test Kit (Swab) EUDAMED
- Model / Reference
- COV Ag-6012H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974246460048 EUDAMED
- Basic UDI-DI
- B-06974246460048 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
COVID-19 Antigen Rapid Test Kit (Swab) by Safecare Biotech (Hangzhou) 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-06974246460048 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Safecare Biotech (hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000019109
- Authorised Representative
- NIC GmbH DE-AR-000033515
Sources (1)
- EUDAMED 9c166de7-7476-408c-bad9-dafaab0ce145 61 fields · synced Oct 7, 2026