Identity
- Trade Name
- Dry Eye Module EUDAMED
- Device Name
- Dry Eye Module EUDAMED
- Model / Reference
- DEM650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945087500422 EUDAMED
- Basic UDI-DI
- 69450875DryEyeModuleAS EUDAMED
- EMDN Code
- Z12129099 VARIOUS OPHTALMOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Dry Eye Module by Shanghai Mediworks Precision Instruments 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 | 69450875DryEyeModuleAS | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Mediworks Precision Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000004251
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c541dde9-8a61-48cf-9dba-c28ef4348d1a 61 fields · synced Jul 21, 2026