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Automated Nucleic Acids Extraction System
EUDAMEDClass A (EU MDR)
Ref 3000000000043Model ANDiS 360
Identity
- Device Name
- Automated Nucleic Acids Extraction System EUDAMED
- Model / Reference
- ANDiS 360 EUDAMED3000000000043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685478515 EUDAMED
- Basic UDI-DI
- 697368547801QK EUDAMED
- Direct Marketing DI
- 06973685478515 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
Automated Nucleic Acids Extraction System by 3D Biomedicine Science & Technology Co., Limited — 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 | 697368547801QK | Class A | Active |
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Manufacturer
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
- EUDAMED SRN
- CN-MF-000020934
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 0f4b5081-c379-4c1d-b984-8c314097d0dd 61 fields · synced Oct 8, 2026