Identity
- Trade Name
- Medical Ultrasound Gel EUDAMED
- Device Name
- Medical Ultrasound Gel EUDAMED
- Model / Reference
- TRL250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975379740601 EUDAMED
- Basic UDI-DI
- 697537974TRL250ZR EUDAMED
- Direct Marketing DI
- 06975379740601 EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Yancheng Tianrun Medical Instrument Factory — 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 | 697537974TRL250ZR | Class I | Active |
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Manufacturer
- Manufacturer
- Yancheng Tianrun Medical Instrument Factory
- EUDAMED SRN
- CN-MF-000021153
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 36641115-4e00-466b-bd63-89609f8ae827 61 fields · synced Oct 6, 2026