Identity
- Trade Name
- Cristal Ultrasound gel "Transound®" EUDAMED
- Device Name
- ECG Electrodes EUDAMEDUltrasound gel EUDAMED
- Model / Reference
- 61.001.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040545318 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304054EFGELULTFU EUDAMED
- Direct Marketing DI
- 08033040545318 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 15857890-26a0-4cd1-96b6-5091d5585d14 61 fields · synced Jun 18, 2026
- EUDAMED bd05cd43-97c3-4b6d-b9c4-30402c6c959e 61 fields · synced Jun 18, 2026