Identity
- Trade Name
- Vitalgel EUDAMED
- Device Name
- Ultrasound gels EUDAMED
- Model / Reference
- GC-15/5 EUDAMEDG-15/5RB EUDAMEDGC-15/5RB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734015308 EUDAMED08427734007228 EUDAMED08427734037218 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
Vitalgel 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 (6)
- EUDAMED 068dc96d-c30d-48d5-a64c-e54516f7e7d2 61 fields · synced Jul 31, 2026
- EUDAMED f438e96f-0c78-4d96-b1b3-7c52863e982d 61 fields · synced May 17, 2026
- EUDAMED ebc8743e-df18-4baf-8fd2-ed7f970c73c1 61 fields · synced May 18, 2026
- EUDAMED 919bcc0b-c6e6-4d40-a7d8-fd80a7f5995b 61 fields · synced Jul 11, 2026
- EUDAMED 9706337c-18be-424f-827b-d29ecdc5b26c 61 fields · synced Jul 14, 2026
- EUDAMED 6ab88622-9ed9-4d63-8b9b-d6050c343f61 61 fields · synced Jul 31, 2026