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Fully Automated Nucleic Acid Extraction System Natch CS3
EUDAMEDClass A (EU MDR)
Ref S-S13B
Identity
- Device Name
- Fully Automated Nucleic Acid Extraction System Natch CS3 EUDAMED
- Model / Reference
- S-S13B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714502 EUDAMED
- Basic UDI-DI
- 69557927SS13B0000001KP EUDAMED
- Direct Marketing DI
- 06955792714502 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Fully Automated Nucleic Acid Extraction System Natch CS3 by Sansure Biotech Inc. — 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 | 69557927SS13B0000001KP | Class A | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c6498bf0-7faf-491b-bbd3-c698b6bc7ad9 61 fields · synced Jul 25, 2026