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Sky GEL Ultrasound Transmission Medical Gel 5000C
EUDAMEDClass I (EU MDR)
Ref SKYGEL5000CModel Sky GELRef SKYGEL260B
Identity
- Trade Name
- Sky GEL Ultrasound Transmission Medical Gel 5000C EUDAMEDSky GEL Ultrasound Transmission Medical Gel EUDAMED
- Device Name
- Ultrasound Transmission Medical Gel EUDAMED
- Model / Reference
- Sky GEL EUDAMEDSKYGEL5000C EUDAMEDSKYGEL260B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810063 EUDAMED09551019810032 EUDAMED
- Basic UDI-DI
- 955101981US-GELGN EUDAMED
- Direct Marketing DI
- 09551019810063 EUDAMED09551019810032 EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I 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
Sky GEL Ultrasound Transmission Medical Gel 5000C by Isd Meditech Sdn. Bhd. — 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 | 955101981US-GELGN | Class I | Active |
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Manufacturer
- Manufacturer
- Isd Meditech Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000043531
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 93171249-098d-4ec9-bc3d-332cb8c3a4fb 61 fields · synced Oct 6, 2026
- EUDAMED 245b32e5-d044-451f-9204-6601ddaf4961 61 fields · synced May 18, 2026