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PCT/CRP Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass IVD General (EU MDR)
Ref /Ref IF5015
Identity
- Trade Name
- PCT/CRP Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- PCT/CRP Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- / EUDAMEDIF5015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414702064 EUDAMED06954414722017 EUDAMED
- Basic UDI-DI
- B-06954414702064 EUDAMED695441470206H2 EUDAMED
- EMDN Code
- W0102069013,W01021109 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Romania EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
PCT/CRP Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414702064 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414702064 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 8cf026cf-3c87-47f4-ad40-d18e5041047b 61 fields · synced Jul 26, 2026
- EUDAMED 8309b717-8912-49f7-9c7d-b5f2876e29a8 61 fields · synced Jul 26, 2026