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Folate Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2137E-25Ref S2137E-100
Identity
- Device Name
- Folate Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2137E-25 EUDAMEDS2137E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742024 EUDAMED06955792742055 EUDAMED
- Basic UDI-DI
- B-06955792742024 EUDAMEDB-06955792742055 EUDAMED
- EMDN Code
- W0102070103 FOLATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Folate Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06955792742024 | Class IVD General | 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 6d3d2e9f-5840-4031-80c6-d5cf52e911ee 61 fields · synced Jul 23, 2026
- EUDAMED 867e3528-1748-4219-a9d4-469a83b8cb9a 61 fields · synced May 19, 2026