← Back to catalogue
Cyfra 21-1 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2014E-100Ref S2014E-75Ref S2014E-200Ref S2014E-50Ref S2014E-150Ref S2014E-25
Identity
- Device Name
- Cyfra 21-1 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2014E-100 EUDAMEDS2014E-75 EUDAMEDS2014E-200 EUDAMEDS2014E-50 EUDAMEDS2014E-150 EUDAMEDS2014E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792737099 EUDAMED06955792737082 EUDAMED06955792737112 EUDAMED06955792737075 EUDAMED06955792737105 EUDAMED06955792737068 EUDAMED
- Basic UDI-DI
- B-06955792737099 EUDAMEDB-06955792737082 EUDAMEDB-06955792737112 EUDAMEDB-06955792737075 EUDAMEDB-06955792737105 EUDAMEDB-06955792737068 EUDAMED
- EMDN Code
- W0102030111 CYFRA 21-1 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
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
Cyfra 21-1 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-06955792737099 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 6e4db789-55fe-4d32-84fb-9cd2322d24d8 61 fields · synced Jul 23, 2026
- EUDAMED 01f72745-191e-4b2b-8d37-839933a3b865 61 fields · synced May 17, 2026
- EUDAMED 605b44bd-6c82-4abc-8c9a-8dcfba650a24 61 fields · synced May 17, 2026
- EUDAMED 1b6bdc5b-c154-414f-9981-1e9999509bef 61 fields · synced May 18, 2026
- EUDAMED c80645a9-85c3-458c-b706-e7e6efdbe856 61 fields · synced May 18, 2026
- EUDAMED ca948c0e-08d2-4502-b354-300f7b9f55ad 61 fields · synced May 19, 2026