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Full-automatic Nucleic Acids ExtractionInstrument
EUDAMEDClass A (EU MDR)
Ref VNP-96
Identity
- Trade Name
- Full-automatic Nucleic Acids Extraction Instrument EUDAMED
- Device Name
- Full-automatic Nucleic Acids ExtractionInstrument EUDAMED
- Model / Reference
- VNP-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739726 EUDAMED
- Basic UDI-DI
- 6973315739726BL EUDAMED
- Direct Marketing DI
- 06973315739726 EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Full-automatic Nucleic Acids ExtractionInstrument by Nanjing Vazyme Medical Technology 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 | 6973315739726BL | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 37e4dbf1-4d1e-4bd9-b802-bb3d84040608 61 fields · synced Oct 8, 2026
- EUDAMED ccc6e0e7-0136-4c5e-b669-3c1f8b2d824a 61 fields · synced Jun 18, 2026