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EpiDirect® MGMT Methylation qPCR Assay
EUDAMEDClass C (EU MDR)
Ref 8300Model EpiDirect® MGMT Methylation qPCR Assay
Identity
- Trade Name
- EpiDirect® MGMT Methylation qPCR Assay EUDAMED
- Device Name
- EpiDirect® MGMT Methylation qPCR Assay EUDAMED
- Model / Reference
- EpiDirect® MGMT Methylation qPCR Assay EUDAMED8300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713915000434 EUDAMED
- Basic UDI-DI
- 5713915ED001LY EUDAMED
- Direct Marketing DI
- 05713915000434 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
EpiDirect® MGMT Methylation qPCR Assay by PentaBase A/S — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5713915ED001LY | Class C | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (1)
- EUDAMED 5199026d-d55e-4796-9c9f-7408ea58ef3b 61 fields · synced Jun 18, 2026