Identity
- Trade Name
- Medmont Corneal Topographer E300 USB FDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Model / Reference
- E300 USB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349221000033 FDA UDI
- FDA Product Code
- HLQ FDA UDI
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1350 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Medmont Corneal Topographer E300 USB by Medmont International Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Medmont International Pty Ltd
Sources (1)
- FDA UDI 04c17965-76ef-4e64-802f-d2849650eeb7 33 fields · synced May 30, 2026