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Calcitonin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2131E-50Ref S2131E-150Ref S2131E-25Ref S2131E-200Ref S2131E-75
Identity
- Device Name
- Calcitonin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2131E-50 EUDAMEDS2131E-150 EUDAMEDS2131E-25 EUDAMEDS2131E-200 EUDAMEDS2131E-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792741676 EUDAMED06955792741706 EUDAMED06955792741669 EUDAMED06955792741713 EUDAMED06955792741683 EUDAMED
- Basic UDI-DI
- B-06955792741676 EUDAMEDB-06955792741706 EUDAMEDB-06955792741669 EUDAMEDB-06955792741713 EUDAMEDB-06955792741683 EUDAMED
- EMDN Code
- W0102060301 CALCITONIN 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
Calcitonin 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-06955792741676 | 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 (5)
- EUDAMED d7b38416-fdbb-424b-b310-c4929db3e767 61 fields · synced Oct 1, 2026
- EUDAMED 30349504-1173-4246-ab30-d5b3b893da2c 61 fields · synced May 17, 2026
- EUDAMED ad37bfc7-e0b5-4e8b-a01a-d442246c44f7 61 fields · synced May 17, 2026
- EUDAMED c92c665f-371e-49e8-81cb-3d364963883d 61 fields · synced May 17, 2026
- EUDAMED 0fb433f0-60fc-411c-975d-9ce809c35ab0 61 fields · synced May 18, 2026