Identity
- Device Name
- Automated CLEIA system EUDAMED
- Model / Reference
- Surelite 8 EUDAMEDSurelite 16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714779 EUDAMED
- Basic UDI-DI
- 69557927Surelite0001XU EUDAMED
- Direct Marketing DI
- 06955792714779 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated CLEIA 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 | 69557927Surelite0001XU | 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 80acd9d3-6117-4ee4-aced-f426ef6629d9 61 fields · synced Jul 29, 2026