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GlassOuse Assistive Device
EUDAMEDClass I (EU MDR)
Ref GlassOuse LinkModel GlassOuseLink
Identity
- Trade Name
- GlassOuse Assistive Device EUDAMED
- Device Name
- GlassOuse Assistive Device EUDAMED
- Model / Reference
- GlassOuseLink EUDAMEDGlassOuse Link EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978224010010 EUDAMED
- Basic UDI-DI
- 697822401GlassOuseLinkJP EUDAMED
- EMDN Code
- Y241203 PROGRAMMABLE REMOTE CONTROLS, HOME AUTOMATION SYSTEMS, CONTROL SATELLITES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
GlassOuse Assistive Device by EnnoPro Group Limited — 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 | 697822401GlassOuseLinkJP | Class I | Active |
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Manufacturer
- Manufacturer
- EnnoPro Group Limited
- EUDAMED SRN
- CN-MF-000047550
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 7632d5f4-5d04-4567-8d09-e1c80d73e95a 61 fields · synced Jun 19, 2026