Identity
- Trade Name
- Hemonitor H1 EUDAMED
- Device Name
- Hemonitor H1 EUDAMED
- Model / Reference
- HMGA101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800076701007 EUDAMED
- Basic UDI-DI
- 88000767HMGA101G2 EUDAMED
- Direct Marketing DI
- 08800076701007 EUDAMED
- EMDN Code
- W02029099 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Hemonitor H1 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 | 88000767HMGA101G2 | 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 620e1ad1-f2fa-47e1-a5ed-d1210cf29e22 61 fields · synced Jul 9, 2026