Identity
- Trade Name
- Optical frame EUDAMED
- Device Name
- Optical frame EUDAMED
- Model / Reference
- Optical frame 88 EUDAMED06979138140008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979138140008 EUDAMED
- Basic UDI-DI
- 6979138148829 EUDAMED
- Direct Marketing DI
- 06979138140008 EUDAMED
- EMDN Code
- Q02100203 METAL AND PLASTIC SPECTACLE FRAMES WITHOUT 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
Optical frame by Danyang Tuomis Glasses 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 | 6979138148829 | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Tuomis Glasses Co., Ltd.
- EUDAMED SRN
- CN-MF-000049626
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 573eeee3-b80b-4e79-857c-adfcf4430d94 61 fields · synced Jun 19, 2026