Identity
- Trade Name
- Sterile Ultrasound Transmission Gel EUDAMED
- Device Name
- Sterile Ultrasound Transmision Gel EUDAMED
- Model / Reference
- 20g EUDAMED10580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971554725807 EUDAMED
- Basic UDI-DI
- 6971554720AXQ EUDAMED
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Ultrasound Transmission Gel by JingFang Precision Medical Device(Shenzhen) Co., Ltd. — 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 | 6971554720AXQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014096
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5dcf65f8-28c2-497c-bef9-7bdd39db7edc 61 fields · synced Oct 6, 2026