Identity
- Trade Name
- CoviDetect EUDAMED
- Device Name
- CoviDetect™ ULTRA COVID-19 Multiplex RT-qPCR Assay EUDAMED
- Model / Reference
- PCR kit EUDAMED8213, 8214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 5713915CD003LE9S EUDAMED
- Basic UDI-DI
- B-5713915CD003LE9S EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
CoviDetect by PentaBase A/S — 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-5713915CD003LE9S | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (2)
- EUDAMED fc5ee14c-effc-4cfa-8079-d9988afa4a9d 61 fields · synced Jun 19, 2026
- EUDAMED fc5ee14c-effc-4cfa-8079-d9988afa4a9d-1 61 fields · synced Jun 9, 2026