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Laminin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2144E-200Ref S2144E-50Ref S2144E-25Ref S2144E-150
Identity
- Device Name
- Laminin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2144E-200 EUDAMEDS2144E-50 EUDAMEDS2144E-25 EUDAMEDS2144E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742499 EUDAMED06955792742451 EUDAMED06955792742444 EUDAMED06955792742482 EUDAMED
- Basic UDI-DI
- B-06955792742499 EUDAMEDB-06955792742451 EUDAMEDB-06955792742444 EUDAMEDB-06955792742482 EUDAMED
- EMDN Code
- W0102039006 LAMININ 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
Laminin 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-06955792742499 | 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 6404f5db-0ac8-4c50-b7e9-4ce690b94dd8 61 fields · synced Jul 29, 2026
- EUDAMED 291ae3a9-ebac-4844-af89-61a388f68ef7 61 fields · synced May 16, 2026
- EUDAMED 138d94c1-5d02-4299-b06e-33415f210d14 61 fields · synced May 17, 2026
- EUDAMED 34c253e9-115d-45ad-bdcd-87bfefd0a7f0 61 fields · synced May 17, 2026