Identity
- Device Name
- Hemonitor H1 Control Set EUDAMED
- Model / Reference
- HMCT001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076701205 EUDAMED
- Basic UDI-DI
- 88000767HMCT001JN EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS EUDAMED
Classification
- Device Class
- Class B 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
New Device
Yes
EUDAMED
Hemonitor H1 Control Set by Genbody Inc. — Class B — 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 | 88000767HMCT001JN | Class B | Active |
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Manufacturer
- Manufacturer
- GenBody Inc.
- EUDAMED SRN
- KR-MF-000043626
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 25310536-765f-4d0c-b98f-e361c51d24f1 61 fields · synced Jun 17, 2026