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Fully Automated Sample Preparation Liquid Handling System
EUDAMEDClass A (EU MDR)
Ref HB-IEX96A
Identity
- Device Name
- Fully Automated Sample Preparation Liquid Handling System EUDAMED
- Model / Reference
- HB-IEX96A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920164 EUDAMED
- Basic UDI-DI
- 697515792HBIEX96AAU EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Fully Automated Sample Preparation Liquid Handling System by Hybribio Medtech Device Co., Ltd — Class A — IVDR — listed in EUDAMED
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 | 697515792HBIEX96AAU | 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 923a4086-a033-4f61-9afa-b413444af36f 61 fields · synced Aug 4, 2026