Identity
- Device Name
- light guide gel EUDAMED
- Model / Reference
- 80g~1000g/bottle EUDAMED80g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974459969901 EUDAMED
- Basic UDI-DI
- 697445996AYLGGVW EUDAMED
- EMDN Code
- M0409 DRESSINGS FOR PHOTO- AND THERMOTHERAPY IN THE FORM OF GELS AND SOLUTIONS 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
light guide gel by Shandong Kenuode Biomedical 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 | 697445996AYLGGVW | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Kenuode Biomedical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000047503
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 677dc944-4c28-41a7-a9b6-d5a21ad1f0ad 61 fields · synced Jun 18, 2026