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Eye Mask
EUDAMEDClass I (EU MDR)
Ref LY-EM02 / 33000Model LY-EM00Ref LY-EM04Ref LY-EM03 / 34000 / 101041
Identity
- Trade Name
- EYE MASK EUDAMED
- Device Name
- EYE MASK EUDAMED
- Model / Reference
- LY-EM00 EUDAMEDLY-EM02 / 33000 EUDAMEDLY-EM04 EUDAMEDLY-EM03 / 34000 / 101041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394400290 EUDAMED06975394400313 EUDAMED06975394400306 EUDAMED
- Basic UDI-DI
- 697539440LYEM00VA EUDAMED
- EMDN Code
- M040399 OPHTHALMIC DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Eye Mask by Linye Health Tech(ningbo)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 | 697539440LYEM00VA | Class I | Active |
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Manufacturer
- Manufacturer
- Linye Health Tech(ningbo)co., Ltd
- EUDAMED SRN
- CN-MF-000024232
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 31e6d78c-7e5c-43e8-86aa-a45b30a2bac3 61 fields · synced Oct 6, 2026
- EUDAMED 62ba8d2e-3b3f-42af-a32a-2e7cad89050a 61 fields · synced May 19, 2026
- EUDAMED e649bd58-652c-4d58-9880-08ead2720d4c 61 fields · synced May 19, 2026