Identity
- Trade Name
- PASCAL LIO EUDAMEDPASCAL LIO, 532nm FDA UDI
- Generic Name
- Indirect binocular laser ophthalmoscope FDA UDI
- Device Name
- Laser Indirect Ophthalmoscope (LIO) EUDAMEDKIT, PASCAL LIO, 532nm, PASCAL Synthesis IRIDEX FDA UDI
- Model / Reference
- SA-06171 EUDAMEDLIO for Synthesis 532 FDA UDI
- Description
- KIT, PASCAL LIO, 532nm, PASCAL Synthesis IRIDEX FDA UDI
Identifiers
- Catalog Number
- SA-06171 FDA UDI
- Primary DI / UDI-DI
- 00813125016807 EUDAMEDFDA UDI
- Basic UDI-DI
- 081312501LIO9E EUDAMED
- 510(k) Number
- K123056 FDA UDI
- FDA Product Code
- HQF FDA UDI
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
- GMDN Term
- Indirect binocular laser ophthalmoscope 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
Pascal Lio 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 | 081312501LIO9E | 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 0f564049-1c4b-45fd-a968-ff31f0184f9b 61 fields · synced Jul 9, 2026
- FDA UDI ec803458-1dbf-474b-ab74-d038199de775 37 fields · synced May 30, 2026