Identity
- Device Name
- Liquid Handling System EUDAMED
- Model / Reference
- HBLH-Mini96A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920171 EUDAMED
- Basic UDI-DI
- 697515792HBLHMINI96AFG EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
New Device
No
EUDAMED
Liquid Handling System by Hybribio Medtech Device Co., Ltd — Class A — 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 | 697515792HBLHMINI96AFG | Class A | Active |
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Manufacturer
- Manufacturer
- Hybribio Medtech Device Co., Ltd
- EUDAMED SRN
- CN-MF-000023113
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED f69758a1-6b0a-4f4a-8ff8-155935a7d058 61 fields · synced Jul 23, 2026