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Cristal ultrasound gel "Transound®"
EUDAMEDClass I (EU MDR)
Ref 61.005.13Ref 61.250.11
Identity
- Trade Name
- Cristal ultrasound gel "Transound®" EUDAMED
- Device Name
- ECG Electrodes EUDAMEDUltrasound gel EUDAMED
- Model / Reference
- 61.005.13 EUDAMED61.250.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040545295 EUDAMED08033040545592 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304054EFGELULTFU EUDAMED
- Direct Marketing DI
- 08033040545295 EUDAMED08033040545592 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
Category: Device sterilization/disinfection container, reusable
Cristal ultrasound gel "Transound®" by EF Medica Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (4)
- EUDAMED 420493ff-db77-4173-9ea0-c1ad03f2e19a 61 fields · synced Jul 25, 2026
- EUDAMED 71befa73-bf26-4be2-9840-f13c43944d40 61 fields · synced May 19, 2026
- EUDAMED 2acae121-f761-4f42-860c-8a095c12e2c7 61 fields · synced Jun 18, 2026
- EUDAMED 2ce2b63b-1ff2-459b-9b6c-cf694f0481e8 61 fields · synced Jul 25, 2026