Identity
- Trade Name
- Sky Gel ECG Gel 5000E EUDAMED
- Device Name
- ECG Gel EUDAMED
- Model / Reference
- Sky GEL EUDAMEDSKYGEL5000E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551019810087 EUDAMED
- Basic UDI-DI
- 955101981ECG-GELB2 EUDAMED
- Direct Marketing DI
- 09551019810087 EUDAMED
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER 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 ECG Gel 5000E 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 | 955101981ECG-GELB2 | 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 (1)
- EUDAMED 2d283f84-f9d9-4e04-b92d-c211e518a9b7 61 fields · synced Jul 15, 2026