Identity
- Trade Name
- KOM-S11451 EUDAMED
- Device Name
- ACETATE SUNGLASSES EUDAMED
- Model / Reference
- KOM-S11451 EUDAMEDACETATE SUNGLASSES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916010151 EUDAMED
- Basic UDI-DI
- 697891601451PS EUDAMED
- Direct Marketing DI
- 06978916010151 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
Kom-S11451 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 | 697891601451PS | 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 1bee7114-8e5b-4819-874b-1953e89078d1 61 fields · synced Jun 19, 2026