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Type Ⅳ Collagen Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2155E-50Ref S2155E-25Ref S2155E-150Ref S2155E-100
Identity
- Device Name
- Type Ⅳ Collagen Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2155E-50 EUDAMEDS2155E-25 EUDAMEDS2155E-150 EUDAMEDS2155E-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792743090 EUDAMED06955792743083 EUDAMED06955792743120 EUDAMED06955792743113 EUDAMED
- Basic UDI-DI
- B-06955792743090 EUDAMEDB-06955792743083 EUDAMEDB-06955792743120 EUDAMEDB-06955792743113 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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
Type Ⅳ Collagen 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-06955792743090 | 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 (4)
- EUDAMED 0b174d24-c7fa-4ee0-b110-6af9a0d5e380 61 fields · synced Jul 29, 2026
- EUDAMED f683a796-8870-4e84-b300-b468213f89fe 61 fields · synced May 16, 2026
- EUDAMED f9ebc1bd-04c7-4d57-b4dc-4fb043bc26a0 61 fields · synced May 18, 2026
- EUDAMED 0873a661-8ec1-44e1-bade-a700b9d9c855 61 fields · synced May 18, 2026