Identity
- Trade Name
- Transonic EUDAMED
- Device Name
- Ultrasound gels EUDAMED
- Model / Reference
- G-15/5RB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734000526 EUDAMED
- Basic UDI-DI
- 8427734USGEL8L EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Transonic 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Telic, S.A.U.
- EUDAMED SRN
- ES-MF-000001853
Sources (2)
- EUDAMED 323bcc98-8ec3-4118-b3d0-e129126a0c92 61 fields · synced Jun 19, 2026
- EUDAMED 4ebe527b-235a-4c1b-98db-bb09769bad65 61 fields · synced Jun 19, 2026