Identity
- Trade Name
- Galilei G6 EUDAMEDGALILEI FDA UDI
- Generic Name
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
- Device Name
- Galilei G4 EUDAMEDGalilei G6 Lens Professional FDA UDI
- Model / Reference
- Galilei G4 EUDAMED410.030.007 EUDAMEDG6 FDA UDI
- Description
- Galilei G6 Lens Professional FDA UDI
Identifiers
- Catalog Number
- 410.030.007 FDA UDI
- Primary DI / UDI-DI
- 07640167751242 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775CMSGALGK EUDAMED
- 510(k) Number
- K182659 FDA UDI
- FDA Product Code
- MXK FDA UDI
- EMDN Code
- Z12120102,Z12120123,Z12120199 EUDAMED
- GMDN Term
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Eye anterior segment analyserOptical low coherence reflectometry (OLCR) biometerCorneal topography system application software
Galilei by SIS AG, Surgical Instrument Systems — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system application software.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SIS AG, Surgical Instrument Systems
Sources (2)
- FDA UDI f52a5a82-27db-4816-9e81-3a892ba413ea 37 fields · synced Jul 24, 2026
- EUDAMED c65c1489-2031-4f46-a6e4-3fc9c243bd4a 61 fields · synced Jul 24, 2026