Identity
- Trade Name
- GALILEI G4 EUDAMEDGALILEI FDA UDI
- Generic Name
- Optical low coherence reflectometry (OLCR) biometer FDA UDI
- Device Name
- Galilei G4 EUDAMEDGalilei Dual Scheimpflug Analyzer FDA UDI
- Model / Reference
- Galilei G4 EUDAMED410.030.004 EUDAMEDG4 FDA UDI
- Description
- Galilei Dual Scheimpflug Analyzer FDA UDI
Identifiers
- Catalog Number
- 410.030.004 FDA UDI
- Primary DI / UDI-DI
- 07640167751235 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775CMSGALGK EUDAMED
- 510(k) Number
- K051940 FDA UDI
- FDA Product Code
- MXK FDA UDI
- EMDN Code
- Z12120121,Z12120123 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
- Spain 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
Yes
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
No
FDA UDI
Galilei G4 by SIS Ltd., Surgical Instrument System — Class IIa — 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 | 764016775CMSGALGK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SIS Ltd., Surgical Instrument System
- EUDAMED SRN
- CH-MF-000025017
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (2)
- EUDAMED cd52e3fc-34fa-420c-9a38-58766ca8e2d7 61 fields · synced Jun 18, 2026
- FDA UDI 901acc33-c972-46b9-b547-5cb2340264a1 37 fields · synced May 30, 2026