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Acetate Sunglasses
EUDAMEDClass I (EU MDR)
Ref 06978916011387Model KOM-S11455Ref 06978916010182Model KOM-S11475Ref 06978916010434Model KOM-S11626Ref 06978916011363Model KOM-S20303Ref 06978916010236Model KOM-S11501
Identity
- Trade Name
- ACETATE SUNGLASSES EUDAMED
- Device Name
- ACETATE SUNGLASSES EUDAMED
- Model / Reference
- KOM-S11455 EUDAMED06978916011387 EUDAMEDKOM-S11475 EUDAMED06978916010182 EUDAMEDKOM-S11626 EUDAMED06978916010434 EUDAMEDKOM-S20303 EUDAMED06978916011363 EUDAMEDKOM-S11501 EUDAMED06978916010236 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978916011387 EUDAMED06978916010182 EUDAMED06978916010434 EUDAMED06978916011363 EUDAMED06978916010236 EUDAMED
- Basic UDI-DI
- 697891601114556W EUDAMED697891601475Q8 EUDAMED697891601626Q5 EUDAMED697891601203036A EUDAMED697891601501PG EUDAMED
- Direct Marketing DI
- 06978916011387 EUDAMED06978916010182 EUDAMED06978916010434 EUDAMED06978916011363 EUDAMED06978916010236 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 | 697891601114556W | 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 (5)
- EUDAMED 7b286cce-f496-414c-b3e7-45ed147f7b3b 61 fields · synced Oct 6, 2026
- EUDAMED a2bc3ff1-527a-404f-bc3e-45a7b00e7dca 61 fields · synced May 17, 2026
- EUDAMED 73388099-4c29-42d0-a8bd-89d1d76f8cbe 61 fields · synced May 18, 2026
- EUDAMED e1760b21-d5d5-46ab-8ca8-d649d748f7e7 61 fields · synced May 18, 2026
- EUDAMED 5dafc7e4-76d3-449e-8ea3-4763a871f0b2 61 fields · synced May 18, 2026