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Fully Automated Nucleic Acid Hybridization System (AutoMax)
EUDAMEDClass A (EU MDR)
Ref HBHM-9000A
Identity
- Device Name
- Fully Automated Nucleic Acid Hybridization System (AutoMax) EUDAMED
- Model / Reference
- HBHM-9000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920065 EUDAMED
- Basic UDI-DI
- 697515792HBHM9000AE6 EUDAMED
- EMDN Code
- W02050101 NUCLEIC ACID HYBRIDIZATION UNITS 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 Nucleic Acid Hybridization System (AutoMax) 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 | 697515792HBHM9000AE6 | 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 7d0ad115-8ac5-4de8-92e1-9b46ca379608 61 fields · synced Jun 19, 2026