Identity
- Trade Name
- Eye Safety Filter, Fixed (532 nm) EUDAMED
- Device Name
- Eye Safety Filter (ESF) EUDAMED
- Model / Reference
- 30365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813125010201 EUDAMED
- Basic UDI-DI
- 081312501ESF8P EUDAMED
- EMDN Code
- Z12120280 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 Safety Filter, Fixed (532 nm) by Iridex Corporation — 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 | 081312501ESF8P | Class I | Active |
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Manufacturer
- Manufacturer
- Iridex Corporation
- EUDAMED SRN
- US-MF-000029814
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3d002ccf-0d91-4b27-ba59-d0a17583c2cd 61 fields · synced Jun 18, 2026