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Gel Imaging System
EUDAMEDClass A (EU MDR)
Ref IN0111Model GEP SeriesRef GEP-GDX5T
Identity
- Trade Name
- Gel Imaging System EUDAMED
- Device Name
- Gel Imaging System EUDAMED
- Model / Reference
- GEP Series EUDAMEDIN0111 EUDAMEDGEP-GDX5T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978507780265 EUDAMED06975488440751 EUDAMED
- Basic UDI-DI
- 697850778CEP11PB EUDAMED697548844GEPI22TJ EUDAMED
- EMDN Code
- W020105019002 GEL DOCUMENTATION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Gel Imaging System by Infitek Co., Ltd. — Class A — 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 | 697850778CEP11PB | Class A | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000048840
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 96662274-ebc2-427c-a2e6-382af1d5920f 61 fields · synced Jul 18, 2026
- EUDAMED 7e680dfb-ea6d-4aff-85f1-6bbe91003879 61 fields · synced May 18, 2026