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Automatic Nucleic Acids Extraction Instrument
EUDAMEDClass A (EU MDR)
Ref VNP-32YL
Identity
- Trade Name
- Automatic Nucleic Acids Extraction Instrument EUDAMED
- Device Name
- Automatic Nucleic Acids Extraction Instrument EUDAMED
- Model / Reference
- VNP-32YL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739597 EUDAMED
- Basic UDI-DI
- 6973315739597BZ EUDAMED
- Direct Marketing DI
- 06973315739597 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
Automatic Nucleic Acids Extraction Instrument by Nanjing Vazyme Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6973315739597BZ | 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 (1)
- EUDAMED 97e06ebd-769e-403b-abc8-0914e19df8a4 61 fields · synced Oct 6, 2026