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Procalcitonin Determination Kit (PCT Determination Kit)
EUDAMEDClass C (EU MDR)
Ref P15001Model 25 tests/box
Identity
- Device Name
- Procalcitonin Determination Kit (PCT Determination Kit) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP15001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182502717 EUDAMED
- Basic UDI-DI
- 697518250P1500168 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
New Device
No
EUDAMED
Procalcitonin Determination Kit (PCT Determination Kit) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250P1500168 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 0310bbd7-bd0a-41dd-b13a-1aec8adf2613 61 fields · synced Oct 6, 2026