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Fully Automated Nucleic Acid Amplification Hybridization Analyzer
EUDAMEDClass A (EU MDR)
Ref 2308HGModel YN-HR9600pro
Identity
- Trade Name
- Fully Automated Nucleic Acid Amplification Hybridization Analyzer EUDAMED
- Device Name
- Fully Automated Nucleic Acid Amplification Hybridization Analyzer EUDAMED
- Model / Reference
- YN-HR9600pro EUDAMED2308HG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931304243 EUDAMED
- Basic UDI-DI
- 695593130023080807M7 EUDAMED
- Direct Marketing DI
- 06955931304243 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Fully Automated Nucleic Acid Amplification Hybridization Analyzer by Yaneng BIOscience (Shenzhen) 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 | 695593130023080807M7 | Class A | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 693843ed-f7f9-4a1e-92b8-83be2bd1f7c1 61 fields · synced Jun 19, 2026