Identity
- Trade Name
- SOLANN EUDAMED
- Device Name
- Ultrasound gels EUDAMED
- Model / Reference
- GC-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734039441 EUDAMED
- Basic UDI-DI
- 8427734USGEL8L EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
Solann 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 47a440a8-0a7f-42b0-ae5f-57c1ab41d1e8 61 fields · synced Jul 12, 2026
- EUDAMED 93a17b8c-ca4e-4867-a3d9-2cee2acec1e2 61 fields · synced Jun 14, 2026