Identity
- Trade Name
- HbA1c Control EUDAMED
- Model / Reference
- FIHBA-PN20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FIHBA-PN20HG5N EUDAMED
- Basic UDI-DI
- B-FIHBA-PN20HG5N EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HbA1c Control 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-FIHBA-PN20HG5N | 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 7064ceac-ab66-4aad-a509-da1044e2039f 61 fields · synced Oct 6, 2026