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Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref 50 Tests/kit（DR1117-1）Model 50 Tests/kitRef 100 Tests/kit（DR1117-2）Model 100 Tests/kitRef 200 Tests/kit（DR1117-3）Model 200 Tests/kit
Identity
- Trade Name
- Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 50 Tests/kit EUDAMED50 Tests/kit（DR1117-1） EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1117-2） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1117-3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981455 EUDAMED06974969982025 EUDAMED06974969982599 EUDAMED
- Basic UDI-DI
- B-06974969981455 EUDAMEDB-06974969982025 EUDAMEDB-06974969982599 EUDAMED
- EMDN Code
- W0102060206 RENINE DIRECT 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
Renin 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-06974969981455 | 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 (3)
- EUDAMED 342561c7-a2e2-4dad-9d26-1b1fecde3b4f 61 fields · synced Jul 27, 2026
- EUDAMED 44d308b3-4313-4e70-af03-a4bd756d63d3 61 fields · synced May 17, 2026
- EUDAMED 4169a11c-25b4-4c90-97b8-51dbaab9788b 61 fields · synced May 18, 2026