Identity
- Trade Name
- ATLAS Review for i. Profiler plus FDA UDI
- Generic Name
- Corneal topography system application software FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- 000000-2360-422 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- 000000-2360-422 FDA UDI
- Primary DI / UDI-DI
- 04250668606632 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Corneal topography system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Corneal topography system application software
ATLAS Review for i. Profiler plus by Carl Zeiss Vision GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corneal topography system application software.
- GALILEI — SIS AG, Surgical Instrument Systems · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
Sources (1)
- FDA UDI 4617a423-0f70-4e88-bae1-5c69bc40abc7 35 fields · synced Jun 1, 2026