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RespiDetect
EUDAMEDClass IVD General (EU MDR)
Ref 8200, 8201Model RT-qPCR Assay
Identity
- Trade Name
- RespiDetect EUDAMED
- Device Name
- RespiDetect Respiratory Panel 1 RT-qPCR Assay EUDAMED
- Model / Reference
- RT-qPCR Assay EUDAMED8200, 8201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5713915CD006LLAP EUDAMED
- Basic UDI-DI
- B-5713915CD006LLAP EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
RespiDetect 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-5713915CD006LLAP | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (2)
- EUDAMED 12fd63c8-05ab-434b-ba8c-86d45551fbb5 61 fields · synced Jun 18, 2026
- EUDAMED 12fd63c8-05ab-434b-ba8c-86d45551fbb5-1 61 fields · synced Jun 10, 2026