Identity
- Trade Name
- ACETATE SUNGLASSES EUDAMED
- Device Name
- ACETATE SUNGLASSES EUDAMED
- Model / Reference
- KOM-S20300 EUDAMED06978916010922 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916010922 EUDAMED
- Basic UDI-DI
- 6978916012030064 EUDAMED
- Direct Marketing DI
- 06978916010922 EUDAMED
- EMDN Code
- Q0210030199 READY TO WEAR SPECTACLES WITH ORGANIC LENSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Acetate Sunglasses by Wenzhou New Standing 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 | 6978916012030064 | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou New Standing Eyewear Co., Ltd.
- EUDAMED SRN
- CN-MF-000030477
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 075815e1-8936-4f5c-8171-220d00828e48 61 fields · synced Jun 17, 2026