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Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref Natch 48Model Natch 24, Natch 48, Natch 96Ref Natch 24SModel Natch 24S, Natch 48S, Natch 96SRef Natch 96SRef Natch 96Ref S-F11ARef Natch 48S
Identity
- Trade Name
- Nucleic Acid Extraction System EUDAMED
- Device Name
- Nucleic Acid Extraction System EUDAMED
- Model / Reference
- Natch 24, Natch 48, Natch 96 EUDAMEDNatch 48 EUDAMEDNatch 24S, Natch 48S, Natch 96S EUDAMEDNatch 24S EUDAMEDNatch 96S EUDAMEDNatch 96 EUDAMEDS-F11A EUDAMEDNatch 48S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792712997 EUDAMED06955792713918 EUDAMED06955792713932 EUDAMED06955792713000 EUDAMED06955792711730 EUDAMED06955792713925 EUDAMED
- Basic UDI-DI
- 69557927Natch000000012L EUDAMED69557927Natch0000001XY EUDAMED69557927SF11A000000153 EUDAMED
- Direct Marketing DI
- 06955792712997 EUDAMED06955792713918 EUDAMED06955792713932 EUDAMED06955792713000 EUDAMED06955792711730 EUDAMED06955792713925 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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
Nucleic Acid Extraction System 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 | 69557927Natch000000012L | 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 (6)
- EUDAMED e1f02190-0689-49df-bf79-a64af8de1362 61 fields · synced Jul 24, 2026
- EUDAMED 630cf977-23b4-4c8e-b78c-f51031edc34e 61 fields · synced May 17, 2026
- EUDAMED 27a06992-a280-4bcc-9957-d20c9ee9eb63 61 fields · synced May 18, 2026
- EUDAMED cb881640-1303-4dd4-a649-d5e141a6267d 61 fields · synced May 18, 2026
- EUDAMED 41581e94-0cde-467d-a0eb-11b6a38d7514 61 fields · synced May 19, 2026
- EUDAMED 50912a0e-141d-4bbb-bbdb-888b45743893 61 fields · synced May 19, 2026