Identity
- Trade Name
- eye-spec EUDAMED
- Device Name
- Reading Glasses EUDAMED
- Model / Reference
- wri-blu100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060939041128 EUDAMED
- Basic UDI-DI
- 506093904EYESPEC01GE EUDAMED
- EMDN Code
- Q0210030201 READY TO WEAR METAL SPECTACLES WITH MINERAL LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
eye-spec by Out of Site 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 | 506093904EYESPEC01GE | Class I | Active |
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Manufacturer
- Manufacturer
- Out of Site Ltd
- EUDAMED SRN
- UK-MF-000042912
- Authorised Representative
- SigmaTech Nordic ApS DK-AR-000039264
Sources (1)
- EUDAMED 2288451c-bc68-4bad-bfcf-4923c4139531 61 fields · synced Jun 18, 2026