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Laminin（LN）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1074-2）Model 100 Tests/kitRef 200 Tests/kit（DR1074-3）Model 200 Tests/kitRef 50 Tests/kit（DR1074-1）Model 50 Tests/kit
Identity
- Trade Name
- Laminin（LN）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Laminin（LN）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1074-2） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1074-3） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1074-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981714 EUDAMED06974969982285 EUDAMED06974969981141 EUDAMED
- Basic UDI-DI
- B-06974969981714 EUDAMEDB-06974969982285 EUDAMEDB-06974969981141 EUDAMED
- EMDN Code
- W0102120199 LIVER FUNCTION - OTHER EUDAMEDW0102039006 LAMININ EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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（LN）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General — IVDD…
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-06974969981714 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (6)
- EUDAMED 1d1234bf-0b0c-4b3e-8d9a-57312bb3cfa2 61 fields · synced Oct 6, 2026
- EUDAMED fdb85aec-3289-4353-b069-ecb459f6a293 61 fields · synced May 19, 2026
- EUDAMED 70bdbce4-c2d1-45ad-98a5-9cf857454557 61 fields · synced May 19, 2026
- EUDAMED 12a6dc37-1814-4d30-a31b-662b7d15cbb5 61 fields · synced Jul 18, 2026
- EUDAMED e912a533-847b-4d47-9261-ffa08b55926f 61 fields · synced Jul 28, 2026
- EUDAMED 2b9e70d7-d46a-4280-bf92-66fb67251e7f 61 fields · synced Jul 30, 2026