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Ultrasound gel "Transound®"
EUDAMEDClass I (EU MDR)
Ref 61.005.01Ref 61.001.01Ref 61.250.01
Identity
- Trade Name
- Ultrasound gel "Transound®" EUDAMED
- Device Name
- ECG Electrodes EUDAMEDUltrasound gel EUDAMED
- Model / Reference
- 61.005.01 EUDAMED61.001.01 EUDAMED61.250.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040545332 EUDAMED08033040545288 EUDAMED08033040545493 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304054EFGELULTFU EUDAMED
- Direct Marketing DI
- 08033040545332 EUDAMED08033040545288 EUDAMED08033040545493 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
Discover the latest ultrasound gel technology from Ultrasound gel "Transound". This non-sterile medical device is designed for use in various medical applications, including ECG monitoring and transcutaneous cardiac stimulation. Our comprehensive database provides detailed information on its features, specifications, and compliance status.
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 (6)
- EUDAMED 29164f1e-b314-4095-8e72-16232caeb8c3 61 fields · synced Jul 21, 2026
- EUDAMED bc2e6b36-e23d-41e3-b4f6-8121ab21642f 61 fields · synced May 17, 2026
- EUDAMED 1260aa2b-9d40-4aa9-82b1-3d05c4e10547 61 fields · synced May 17, 2026
- EUDAMED 94c54382-2c06-4bc8-b494-bba57c8ed16c 61 fields · synced Jul 17, 2026
- EUDAMED be6b1913-faa2-4fd6-98cc-30fd15587a70 61 fields · synced Jul 20, 2026
- EUDAMED ce7d6fc1-904f-40f5-8d84-8bb488255422 61 fields · synced Jul 21, 2026