Identity
- Trade Name
- PTS 2000 EUDAMEDAutomated Projection Perimeter FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- Automated Projection Perimeter EUDAMEDThe PTS 2000 automated projection 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 2000 EUDAMEDFDA UDIREF 770-001 EUDAMED
- Description
- The PTS 2000 automated projection 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
- 770-001 FDA UDI
- Primary DI / UDI-DI
- 05903293141113 EUDAMEDFDA UDI
- Basic UDI-DI
- 5903293141770000DC EUDAMED
- Direct Marketing DI
- 05903293141113 EUDAMED
- FDA Product Code
- HPT FDA UDI
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1605 FDA UDI
- Market of Registration
- Poland 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
No
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
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
Pts 2000 by Optopol Technology Sp Z O O — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Perimeter, automatic.
- VisuALL VRP S — Olleyes, Inc. · Class I
- Medmont Automated Perimeter M700 USB — MEDMONT INTERNATIONAL PTY LTD · Class I
- PalmScan VF2000 — MICRO MEDICAL DEVICES, INC. · Class I
- 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 (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 | 5903293141770000DC | Class I | Active |
| 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
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED 17b1397e-6d1b-483d-80a9-928f9393c2dd 61 fields · synced Jun 19, 2026
- FDA UDI 48991147-7cae-4e3f-a7ad-aec568c599e7 34 fields · synced May 30, 2026