Identity
- Trade Name
- EyeGuardian EUDAMED
- Device Name
- EYE COVER EUDAMED
- Model / Reference
- 42593-IN EUDAMED49369-IN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817518023106 EUDAMED00817518023113 EUDAMED
- Basic UDI-DI
- 081751802EYECOVERIEF EUDAMED
- EMDN Code
- M040306 OPHTHALMIC PROTECTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
EyeGuardian by Marketlab Inc. — 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 | 081751802EYECOVERIEF | Class I | Active |
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Manufacturer
- Manufacturer
- Marketlab, Inc.
- EUDAMED SRN
- US-MF-000010723
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 04e532ab-d078-447b-bd3a-8fe062d31ee4 61 fields · synced Jul 30, 2026
- EUDAMED d70aa266-a084-40c2-9d17-a32556aadf04 61 fields · synced May 18, 2026