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2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva）
EUDAMEDClass IVD General (EU MDR)
Ref K711616D
Identity
- Trade Name
- 2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva） EUDAMED
- Model / Reference
- K711616D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792050792 EUDAMED
- Basic UDI-DI
- B-06971792050792 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&Saliva） by Hangzhou Realy Tech Co., Ltd. — Class IVD General — 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-06971792050792 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ab1611e3-e52d-4c12-9d1b-d48414882578 61 fields · synced Jun 18, 2026