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ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)
EUDAMEDClass IVD General (EU MDR)
Ref 301069
Identity
- Trade Name
- ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) EUDAMED
- Device Name
- ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) EUDAMED
- Model / Reference
- 301069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885013953824 EUDAMED
- Basic UDI-DI
- B-08885013953824 EUDAMED
- EMDN Code
- W0105040519 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
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) by Vela Operations Singapore Pte. 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-08885013953824 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
- EUDAMED SRN
- SG-MF-000025684
- Authorised Representative
- Vela Diagnostics Germany GmbH DE-AR-000016088
Sources (1)
- EUDAMED 6d059e61-1084-4d17-86cc-75539d66d34a 61 fields · synced Oct 6, 2026