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optical glasses
EUDAMEDClass I (EU MDR)
Ref LCW10057C1Model LCW238 LCW261 LCW262 LCW264 LCW265 LCW266 LCW275 LCW280 LCW281 LCW287 LCW289 LCW297 LCW300 LCW304 LCW312 LCW314 LCW10057 LCW10056 LCW10053 LCW10050 LCW10030 LCW10026 LCW10043 LCW10041 LCW10040 LCW10035
Identity
- Trade Name
- optical glasses EUDAMED
- Device Name
- Lee Cooper EUDAMED
- Model / Reference
- LCW238 LCW261 LCW262 LCW264 LCW265 LCW266 LCW275 LCW280 LCW281 LCW287 LCW289 LCW297 LCW300 LCW304 LCW312 LCW314 LCW10057 LCW10056 LCW10053 LCW10050 LCW10030 LCW10026 LCW10043 LCW10041 LCW10040 LCW10035 EUDAMEDLCW10057C1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975944902106 EUDAMED
- Basic UDI-DI
- 697594490LCWOVA EUDAMED
- EMDN Code
- K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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 glasses by Wenzhou Changhui International Trade 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 | 697594490LCWOVA | Class I | Active |
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Manufacturer
- Manufacturer
- Wenzhou Changhui International Trade Co., Ltd.
- EUDAMED SRN
- CN-MF-000031322
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED 59728dc2-4410-46ad-ac6a-69ee2aa05b8c 61 fields · synced Jun 18, 2026