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PCT (Procalcitonin) Rapid Quantitative Test
EUDAMEDClass IVD General (EU MDR)
Ref PCT
Identity
- Trade Name
- PCT (Procalcitonin) Rapid Quantitative Test EUDAMED
- Device Name
- PCT (Procalcitonin) Rapid Quantitative Test EUDAMED
- Model / Reference
- PCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975679490466 EUDAMED
- Basic UDI-DI
- B-06975679490466 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
PCT (Procalcitonin) Rapid Quantitative Test by Hunan Ehome Health Technology Company Limited — Class IVD General — IVDD — listed in EUDAMED
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-06975679490466 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Ehome Health Technology Company Limited
- EUDAMED SRN
- CN-MF-000045177
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED a3961647-3b52-4f74-bd02-94f8171257e9 61 fields · synced Jun 18, 2026