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IL-6 Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass B (EU MDR)
Ref IF5088
Identity
- Trade Name
- IL-6 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- IL-6 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- IF5088 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414792904 EUDAMED
- Basic UDI-DI
- 695441470272HF EUDAMED
- EMDN Code
- W01030609 INTERLEUKIN 6 (IL-6) EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
IL-6 Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 695441470272HF | Class B | 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 (1)
- EUDAMED ec7eef08-6104-4aa6-b6ad-b444f550d909 61 fields · synced Jun 19, 2026