Identity
- Device Name
- Ready-to-wear spectacles EUDAMED
- Model / Reference
- Ready-to-wear spectacles EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977212120007 EUDAMED
- Basic UDI-DI
- 697721212101GW EUDAMED
- EMDN Code
- Q0210030103 READY TO WEAR METAL AND PLASTIC SPECTACLES WITH ORGANIC 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
Ready-to-wear spectacles by Guangzhou Huaju Information 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 | 697721212101GW | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou Huaju Information Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000040082
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED ea7588af-4b15-47c2-8e18-37dcff902289 61 fields · synced Jun 18, 2026