Identity
- Trade Name
- VITA+ Ultrasonic Gel EUDAMED
- Device Name
- Ultrasound gels EUDAMED
- Model / Reference
- GC15/05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734039502 EUDAMED
- Basic UDI-DI
- 8427734USGEL8L EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
VITA+ Ultrasonic Gel by Telic, S.A.U. — 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 | 8427734USGEL8L | Class I | Active |
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Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (2)
- EUDAMED 9e45dd79-0e39-4028-98ec-0de98c399c81 61 fields · synced Jul 9, 2026
- EUDAMED 319bcd76-89f8-4d35-93e4-e7b2d88c14f7 61 fields · synced Jul 9, 2026