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PCT STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510404Model 2×100TRef 0320510401Model 50TRef 0320510403Model 100T
Identity
- Trade Name
- PCT STAT (eCLIA) EUDAMED
- Device Name
- PCT STAT (eCLIA) EUDAMED
- Model / Reference
- 2×100T EUDAMED0320510404 EUDAMED50T EUDAMED0320510401 EUDAMED100T EUDAMED0320510403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063010 EUDAMED06975984062983 EUDAMED06975984063003 EUDAMED
- Basic UDI-DI
- B-06975984063010 EUDAMEDB-06975984062983 EUDAMEDB-06975984063003 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
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 STAT (eCLIA) by Shenzhen Lifotronic 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-06975984063010 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED bfd275f0-fb48-4337-8d8b-07250bc0dda8 61 fields · synced Jul 10, 2026
- EUDAMED b234aaab-3a76-414e-9f8f-127e0d2f181e 61 fields · synced May 17, 2026
- EUDAMED 8e27ae0c-3949-4346-abc7-6b01d19f50cc 61 fields · synced May 18, 2026