Identity
- Trade Name
- optical frames EUDAMED
- Device Name
- Optical frames EUDAMED
- Model / Reference
- 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977890110017 EUDAMED
- Basic UDI-DI
- 697789011QOAYA EUDAMED
- EMDN Code
- Q02100299 SPECTACLE FRAMES WITHOUT LENSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
optical frames by Wenzhou Qixin Eyewear 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 | 697789011QOAYA | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Qixin Eyewear Co., Ltd.
- EUDAMED SRN
- CN-MF-000023969
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 8e1f034e-5d5b-44cd-a70f-8b6c4a88379c 61 fields · synced Jul 14, 2026