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Procalcitonin
EUDAMEDClass IVD General (EU MDR)
Ref 12600786Model Procalcitonin Reagent Kit
Identity
- Trade Name
- Procalcitonin EUDAMED
- Device Name
- Procalcitonin Reagent Kit EUDAMED
- Model / Reference
- Procalcitonin Reagent Kit EUDAMED12600786 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06934175046294QT EUDAMED
- Basic UDI-DI
- B-06934175046294QT EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Procalcitonin by Changsha Sinocare Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06934175046294QT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ace440e8-cc84-4e90-8ee3-a187f15201e7 61 fields · synced Jun 17, 2026