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Eu-Gen MTHFR Dual-Type (25 Test)
EUDAMEDClass C (EU MDR)
Ref 9463SModel Eu-Gen MTHFR Dual-Type
Identity
- Trade Name
- Eu-Gen MTHFR Dual-Type (25 Test) EUDAMED
- Device Name
- Eu-Gen MTHFR Dual-Type (100 Test)/(25 Test) EUDAMED
- Model / Reference
- Eu-Gen MTHFR Dual-Type EUDAMED9463S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08028169208916 EUDAMED
- Basic UDI-DI
- 802816920CW01060402055E EUDAMED
- EMDN Code
- W0106010499 POLYMORPHISM TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Eu-Gen MTHFR Dual-Type (25 Test) by Eurospital Spa — 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 | 802816920CW01060402055E | Class C | Active |
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Manufacturer
- Manufacturer
- Eurospital Spa
- EUDAMED SRN
- IT-MF-000028468
Sources (1)
- EUDAMED df466f2c-53d3-411d-90f4-bfb28e4b587d 61 fields · synced Jun 18, 2026