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EpiDirect® MLH1 Methylation qPCR Assay
EUDAMEDClass C (EU MDR)
Ref 8401;8400Model MLH1 Methylation qPCR Assay
Identity
- Trade Name
- EpiDirect® MLH1 Methylation qPCR Assay EUDAMED
- Device Name
- EpiDirect® MLH1 Methylation qPCR Assay EUDAMED
- Model / Reference
- MLH1 Methylation qPCR Assay EUDAMED8401;8400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713915001417 EUDAMED
- Basic UDI-DI
- 5713915ED002M2 EUDAMED
- Direct Marketing DI
- 05713915001417 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
Yes
EUDAMED
EpiDirect® MLH1 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 | 5713915ED002M2 | Class C | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (2)
- EUDAMED 26722e82-b80f-4695-bf41-a9fab9941410 61 fields · synced Jun 18, 2026
- EUDAMED 26722e82-b80f-4695-bf41-a9fab9941410-1 61 fields · synced Jun 10, 2026