Identity
- Trade Name
- Visuscout 100 set FN FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- Visuscout 100 set FDA UDI
- Model / Reference
- 60100054A FDA UDI
- Description
- Visuscout 100 set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430046260634 FDA UDI
- 510(k) Number
- K132186 FDA UDI
- FDA Product Code
- HKI FDA UDI
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Ophthalmic fundus camera
Visuscout 100 set FN by Optomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VISUCAM 224 — Carl Zeiss Meditec AG · Class II
- NON-MYDRIATIC RETINAL CAMERA TRC-NW400 — Topcon Corp. · Class II
Cleared under the same submission
K132186 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Optomed Corp.
Sources (1)
- FDA UDI 7818df01-8e2f-4d74-9f37-28923743bad3 34 fields · synced May 30, 2026