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Procalcitonin STAT (EECL)
EUDAMEDClass IVD General (EU MDR)
Ref 1020302000Model 50 tests/kitRef 1020301000Model 25 tests/kit
Identity
- Device Name
- Procalcitonin STAT (EECL) EUDAMED
- Model / Reference
- 50 tests/kit EUDAMED1020302000 EUDAMED25 tests/kit EUDAMED1020301000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090501253 EUDAMED06975090500256 EUDAMED
- Basic UDI-DI
- B-06975090501253 EUDAMEDB-06975090500256 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 STAT (EECL) by Accucise Diagnostics 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-06975090501253 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 7d762dea-cefc-490d-8629-8987d226d00e 61 fields · synced Jul 17, 2026
- EUDAMED d5fa4c0d-ef12-434a-a8fc-2eaa798fd8fc 61 fields · synced May 19, 2026