Identity
- Trade Name
- Cristal Ultrasound gel "Transound®" EUDAMED
- Device Name
- ECG Electrodes EUDAMEDUltrasound gel EUDAMED
- Model / Reference
- 61.005.12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040545448 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304054EFGELULTFU EUDAMED
- Direct Marketing DI
- 08033040545448 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Cristal Ultrasound gel "Transound®" by EF Medica Srl — 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 | 803304054EFELEECGBR | Class I | Active |
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Manufacturer
- Manufacturer
- EF Medica Srl
- EUDAMED SRN
- IT-MF-000009938
Sources (2)
- EUDAMED c136f6f5-828d-434c-ab91-757ecd1b274f 61 fields · synced Jun 19, 2026
- EUDAMED 5dbf0229-ac77-44b3-86ef-5b3814d24df5 61 fields · synced Jun 19, 2026