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Fully Automated Nucleic Acid Processing System
EUDAMEDClass A (EU MDR)
Ref S-S13E-PModel S-S13E-P; S-S13E-P1Ref S-S13E-P1
Identity
- Device Name
- Fully Automated Nucleic Acid Processing System EUDAMED
- Model / Reference
- S-S13E-P; S-S13E-P1 EUDAMEDS-S13E-P EUDAMEDS-S13E-P1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792701724 EUDAMED06955792701731 EUDAMED
- Basic UDI-DI
- 69557927SS13EP00000162 EUDAMED
- Direct Marketing DI
- 06955792701724 EUDAMED06955792701731 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Category: Nucleic acid sample preparation instrument IVD
Fully Automated Nucleic Acid Processing System by Sansure Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69557927SS13EP00000162 | 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 (2)
- EUDAMED dc81a60a-2869-4287-8c7c-b723496ba8fb 61 fields · synced Jul 11, 2026
- EUDAMED 0128a35a-38a4-4b1b-acc1-f8fce5d6afb1 61 fields · synced May 17, 2026