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Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2057E-150Ref S2057E-200Ref S2057E-25
Identity
- Device Name
- Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2057E-150 EUDAMEDS2057E-200 EUDAMEDS2057E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792740242 EUDAMED06955792740259 EUDAMED06955792740204 EUDAMED
- Basic UDI-DI
- B-06955792740242 EUDAMEDB-06955792740259 EUDAMEDB-06955792740204 EUDAMED
- EMDN Code
- W0102050212 SOLUBLE FMS-LIKE TYROSINE KINASE-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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Soluble Fms‑like Tyrosine Kinase‑1 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06955792740242 | 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 (3)
- EUDAMED 05e9ab09-0103-4fb0-ba90-cbb903428434 61 fields · synced Oct 6, 2026
- EUDAMED 5ac66cfe-286f-4509-abd5-b0b1a6bb2bb3 61 fields · synced May 17, 2026
- EUDAMED 8093f3cb-42c5-4b0e-8ad3-d677c6ac826b 61 fields · synced May 19, 2026