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Automatic Nucleic Acid Extractor
EUDAMEDClass IVD General (EU MDR)
Ref 18-06-0004Model NEX-96
Identity
- Trade Name
- Automatic Nucleic Acid Extractor EUDAMED
- Device Name
- Automatic Nucleic Acid Extractor EUDAMED
- Model / Reference
- NEX-96 EUDAMED18-06-0004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674891339 EUDAMED
- Basic UDI-DI
- B-06974674891339 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IVD General 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
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Extractor by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid sample preparation instrument IVD.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974674891339 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d17471fd-f6ae-44a3-a240-e3c836a54de2 61 fields · synced Jun 18, 2026