Identity
- Device Name
- Gene Scoper EUDAMED
- Model / Reference
- MFIA02-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-81649002MFIA02F7JY EUDAMED
- Basic UDI-DI
- B-81649002MFIA02F7JY EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Gene Scoper by Healgen Scientific Limited Liability Company — 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-81649002MFIA02F7JY | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Healgen Scientific Limited Liability Company
- EUDAMED SRN
- US-MF-000018839
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c93fb1e8-b92a-4efa-a9ef-682b3fc42851 61 fields · synced Jul 24, 2026