Identity
- Trade Name
- PCT(CLIA) EUDAMED
- Device Name
- PCT(CLIA) EUDAMED
- Model / Reference
- MCL02101E EUDAMEDMCL02102E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603581 EUDAMED06926802603598 EUDAMED
- Basic UDI-DI
- B-06926802603598 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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(clia) by Medcaptain Medical Technology Co., Ltd. — 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-06926802603598 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED e763c2c1-0023-4fb0-bb48-4a2d3c29bd73 61 fields · synced Jul 29, 2026
- EUDAMED 8c023ebd-ced2-47a8-84b7-616c4c1818d9 61 fields · synced May 18, 2026