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Angiotensin II (AII) Detection Kit（Magnetic Solid Phase Chemiluminescent Immuno…
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1118-3）Model 200 Tests/kitRef 100 Tests/kit（DR1118-2）Model 100 Tests/kitRef 50 Tests/kit（DR1118-1）Model 50 Tests/kit
Identity
- Trade Name
- Angiotensin II (AII) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Angiotensin II (AII) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 200 Tests/kit EUDAMED200 Tests/kit（DR1118-3） EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1118-2） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1118-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982759 EUDAMED06974969982742 EUDAMED06974969982735 EUDAMED
- Basic UDI-DI
- B-06974969982759 EUDAMEDB-06974969982742 EUDAMEDB-06974969982735 EUDAMED
- EMDN Code
- W0102060202 ANGIOTENSIN I / II 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
Angiotensin II (AII) Detection Kit（Magnetic Solid Phase Chemiluminescent Immuno… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969982759 | 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 e27256f6-3cbf-4822-881e-7ee31b3ddc73 61 fields · synced Oct 6, 2026
- EUDAMED 6742bf45-0d57-4929-8142-6c36855f7df1 61 fields · synced May 18, 2026
- EUDAMED e2a815d3-5821-4b1c-bd8c-c2b36f7796a7 61 fields · synced May 18, 2026