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MicroSight® MSI 1-Step HRM Analysis
EUDAMEDClass C (EU MDR)
Ref 7201Model MicroSight® MSI 1-Step HRM Analysis
Identity
- Trade Name
- MicroSight® MSI 1-Step HRM Analysis EUDAMED
- Device Name
- MicroSight® MSI 1-Step HRM Analysis EUDAMED
- Model / Reference
- MicroSight® MSI 1-Step HRM Analysis EUDAMED7201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05713915000441 EUDAMED
- Basic UDI-DI
- 5713915MS001SZ EUDAMED
- Direct Marketing DI
- 05713915000441 EUDAMED
- EMDN Code
- W01060214 COLORECTAL CANCER (MSI-H / DMMR) 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
MicroSight® MSI 1-Step HRM Analysis 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 | 5713915MS001SZ | Class C | Active |
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Manufacturer
- Manufacturer
- PentaBase A/S
- EUDAMED SRN
- DK-MF-000023157
Sources (1)
- EUDAMED 4ef3f9e2-f144-4644-841e-1c38b3fdf953 61 fields · synced Jul 20, 2026