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Ferritin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2017E-50Ref S2017E-25Ref S2017E-200Ref S2017E-100Ref S2017E-75Ref S2017E-150
Identity
- Device Name
- Ferritin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2017E-50 EUDAMEDS2017E-25 EUDAMEDS2017E-200 EUDAMEDS2017E-100 EUDAMEDS2017E-75 EUDAMEDS2017E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737259 EUDAMED06955792737242 EUDAMED06955792737297 EUDAMED06955792737273 EUDAMED06955792737266 EUDAMED06955792737280 EUDAMED
- Basic UDI-DI
- B-06955792737259 EUDAMEDB-06955792737242 EUDAMEDB-06955792737297 EUDAMEDB-06955792737273 EUDAMEDB-06955792737266 EUDAMEDB-06955792737280 EUDAMED
- EMDN Code
- W0102070102 FERRITIN 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
Ferritin 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-06955792737259 | 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 (6)
- EUDAMED 9e71276e-2b77-49f0-88da-7a70d47f6aa9 61 fields · synced Jul 30, 2026
- EUDAMED eea24545-5486-482a-a2ca-0264d4432c04 61 fields · synced May 18, 2026
- EUDAMED 7ef6ce3c-c4e4-4b8d-ae7d-e0de1fdcb561 61 fields · synced May 18, 2026
- EUDAMED 23013a69-6626-44ef-a8e4-5766150b1a22 61 fields · synced May 18, 2026
- EUDAMED 3461a165-5545-4207-bf2b-61083d8f8756 61 fields · synced May 19, 2026
- EUDAMED 6d123660-9509-4955-9958-508d45875029 61 fields · synced May 19, 2026