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Medical ultrasound gel
EUDAMEDClass I (EU MDR)
Ref 5gModel 5g,8g,10g,12g,15g,20g,30g,50g,82g,100g,120g,150g，180g，200g，250g，300g，500g，1Kg，1.25Kg，1.3Kg，2.5Kg，5Kg，or customized
Identity
- Device Name
- Medical ultrasound gel EUDAMED
- Model / Reference
- 5g,8g,10g,12g,15g,20g,30g,50g,82g,100g,120g,150g，180g，200g，250g，300g，500g，1Kg，1.25Kg，1.3Kg，2.5Kg，5Kg，or customized EUDAMED5g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921435100018 EUDAMED
- Basic UDI-DI
- 69214351MUG01LR EUDAMED
- EMDN Code
- Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Foshan Pingchuang Medical Technology 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 | 69214351MUG01LR | Class I | Active |
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Manufacturer
- Manufacturer
- Foshan Pingchuang Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000039000
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED d23afc42-1a4a-4b66-b666-147c131cd922 61 fields · synced Jun 19, 2026