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Procalcitonin (PCT) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoa…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1042-2）Model 100 Tests/kitRef 50 Tests/kit（DR1042-1）Model 50 Tests/kitRef 200 Tests/kit（DR1042-3）Model 200 Tests/kit
Identity
- Trade Name
- Procalcitonin (PCT) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Procalcitonin (PCT) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1042-2） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1042-1） EUDAMED200 Tests/kit EUDAMED200 Tests/kit（DR1042-3） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981684 EUDAMED06974969981110 EUDAMED06974969982254 EUDAMED
- Basic UDI-DI
- B-06974969981684 EUDAMEDB-06974969981110 EUDAMEDB-06974969982254 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN 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
Procalcitonin (PCT) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoa… 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-06974969981684 | 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 7f911135-1bf6-4439-b8bb-ad392c88d463 61 fields · synced Oct 6, 2026
- EUDAMED 274e0907-eb73-4ae8-8402-e5e55d0a1889 61 fields · synced May 17, 2026
- EUDAMED efbfccdc-a988-4365-9999-813b258b918e 61 fields · synced May 19, 2026