Identity
- Trade Name
- OXD EUDAMED
- Device Name
- Ultrasound gels EUDAMED
- Model / Reference
- US-B5R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734032114 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
Oxd 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 (1)
- EUDAMED 67655e50-54c7-4eb1-a3fd-efda723b11c1 61 fields · synced Jun 18, 2026