Identity
- Trade Name
- Gymna Contact gel 500 ml EUDAMED
- Device Name
- Ultrason gel EUDAMED
- Model / Reference
- GU-US500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05425029892538 EUDAMED
- Basic UDI-DI
- 542502989USUN EUDAMED
- Direct Marketing DI
- 05425029892538 EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Gymna Contact gel 500 ml by Naqi NV — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 542502989USUN | Class I | Active |
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Manufacturer
- Manufacturer
- Naqi NV
- EUDAMED SRN
- BE-MF-000001241
Sources (1)
- EUDAMED 3e2d72b0-d814-4208-8434-199c8117c8f7 61 fields · synced Jul 14, 2026