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Automated Nucleic Acid Extraction and Amplification System
EUDAMEDClass A (EU MDR)
Ref HBQW-3200A
Identity
- Device Name
- Automated Nucleic Acid Extraction and Amplification System EUDAMED
- Model / Reference
- HBQW-3200A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975157920010 EUDAMED
- Basic UDI-DI
- 697515792HBQW3200AMD 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
Category: Nucleic acid sample preparation instrument IVD
Automated Nucleic Acid Extraction and Amplification System by Hybribio Medtech Device Co., Ltd — Class A — IVDR — listed in EUDAMED
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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 | 697515792HBQW3200AMD | 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 f3d25698-151e-43fe-b5ec-9315df07ec2f 61 fields · synced Jul 9, 2026