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Red Blood Cell Folate Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2138E-75Ref See IFU.Ref S2138E-50
Identity
- Device Name
- Red Blood Cell Folate Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2138E-75 EUDAMEDSee IFU. EUDAMEDS2138E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742109 EUDAMED06955792742086 EUDAMED06955792742093 EUDAMED
- Basic UDI-DI
- B-06955792742109 EUDAMEDB-06955792742086 EUDAMEDB-06955792742093 EUDAMED
- EMDN Code
- W0102070301 VITAMIN B 12 / 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
Red Blood Cell 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-06955792742109 | 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 (3)
- EUDAMED 993dd001-837f-497d-b5d0-8c4b21de7f2d 61 fields · synced Jul 16, 2026
- EUDAMED 41c12897-ac28-4f28-8b41-eea95b1cd781 61 fields · synced May 17, 2026
- EUDAMED cd9181ee-6807-4362-91bb-1b72ae3b79d1 61 fields · synced May 18, 2026