Identity
- Trade Name
- Automated Perimeter FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- The PTS 925 automated perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas. FDA UDI
- Model / Reference
- PTS 925 FDA UDI
- Description
- The PTS 925 automated perimeter is a diagnostic instrument intended for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas. FDA UDI
Identifiers
- Catalog Number
- 765-003 FDA UDI
- Primary DI / UDI-DI
- 05903293141144 FDA UDI
- FDA Product Code
- HPT FDA UDI
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1605 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
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
Yes
FDA UDI
Category: Perimeter, automatic
Automated Perimeter by Optopol Technology Sp Z O O — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- COMPASS — CENTERVUE S.P.A. · Class IIa
- Virtual Eye Software — VIRTUAL VISION HEALTH · Class I
- Virtual Field — Field Virtual Inc · Class I
- VisionOne — PeriVision SA · Class I
- Twinfield 3 — OCULUS Optikgeräte GmbH · Class I
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
- Optopol Technology Sp Z O O
Sources (1)
- FDA UDI 9453d0ab-7f02-4f21-8241-d76da3a34bfa 34 fields · synced May 30, 2026