Identity
- Trade Name
- HemoTrol Duo Normal EUDAMED
- Device Name
- HemoTrol Duo Normal EUDAMED
- Model / Reference
- AN01637A02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AN01637A0228 EUDAMED
- Basic UDI-DI
- B-AN01637A0228 EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HemoTrol Duo Normal by Eurotrol B.V. — 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-AN01637A0228 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (1)
- EUDAMED c8e64188-3c78-4f74-b502-a258908ad887 61 fields · synced Jul 28, 2026