Identity
- Trade Name
- Medical Ultrasound Gel EUDAMED
- Device Name
- Medical Ultrasound Gel EUDAMED
- Model / Reference
- 250ml Smart EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950689130205 EUDAMED
- Basic UDI-DI
- 69506891GEL002LX EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
Medical Ultrasound Gel by Shanghai Shenfeng Medical&Health Articles 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 | 69506891GEL002LX | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Shenfeng Medical&Health Articles Co., Ltd
- EUDAMED SRN
- CN-MF-000012676
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4c06090f-b0a3-4f2e-8aa7-182db9b69b97 61 fields · synced Jun 19, 2026