Identity
- Trade Name
- Eye Safety Two-Position, (532 nm) EUDAMEDEye Safety Filter, Two-Position (532 nm) FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Eye Safety Filter (ESF) EUDAMEDFor use on the Zeiss Dovetails OD3 @ 532 nm FDA UDI
- Model / Reference
- 65475 EUDAMEDFDA UDI
- Description
- For use on the Zeiss Dovetails OD3 @ 532 nm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813125014520 EUDAMEDFDA UDI
- Basic UDI-DI
- 081312501ESF8P EUDAMED
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12120280 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Eye Safety Two-Position, (532 nm) by Iridex Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081312501ESF8P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Iridex Corporation
- EUDAMED SRN
- US-MF-000029814
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1976a6a3-5288-4dde-a7f1-341d35fee22c 61 fields · synced Jul 9, 2026
- FDA UDI d2ca7db1-dfa0-4f23-af19-fb4a2d6b513f 34 fields · synced May 30, 2026