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Thrombomodulin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2062E-200Ref S2062E-25Ref S2062E-150Ref S2062E-75Ref S2062E-50
Identity
- Device Name
- Thrombomodulin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2062E-200 EUDAMEDS2062E-25 EUDAMEDS2062E-150 EUDAMEDS2062E-75 EUDAMEDS2062E-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740556 EUDAMED06955792740501 EUDAMED06955792740549 EUDAMED06955792740525 EUDAMED06955792740518 EUDAMED
- Basic UDI-DI
- B-06955792740556 EUDAMEDB-06955792740501 EUDAMEDB-06955792740549 EUDAMEDB-06955792740525 EUDAMEDB-06955792740518 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER 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
Thrombomodulin 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-06955792740556 | 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 e1aec3d2-40f4-4a05-bbcd-3bad53595673 61 fields · synced Aug 3, 2026
- EUDAMED 7b4d962f-edda-4b01-90c7-da5f3132feff 61 fields · synced May 16, 2026
- EUDAMED 74d4e816-2179-40c0-b777-3a6fe63ba4c6 61 fields · synced May 17, 2026
- EUDAMED 297c1be1-d516-43aa-aadd-9e85d60e5d2f 61 fields · synced May 19, 2026
- EUDAMED e2fd3fa4-aa07-426a-8729-960a458d96e7 61 fields · synced May 19, 2026