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Fully Automated Nucleic Acid Extraction System (AutoPrep)
EUDAMEDClass A (EU MDR)
Ref HBNP-4801A
Identity
- Device Name
- Fully Automated Nucleic Acid Extraction System (AutoPrep) EUDAMED
- Model / Reference
- HBNP-4801A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920089 EUDAMED
- Basic UDI-DI
- 697515792HBNP4801AJP 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 Nucleic Acid Extraction System (AutoPrep) 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 | 697515792HBNP4801AJP | 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 5c6b2c70-1c13-4431-9402-142789905559 61 fields · synced Jul 29, 2026