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Pts 920

by OPTOPOL Technology Sp. z o.o.

Ref REF 760-001

Pts 920 (REF 760-001) is a Class I device made by Optopol Technology Sp Z O O, registered in EUDAMED on 24 Jun 2022 (Basic UDI-DI 5903293141760000CZ) and listed in FDA GUDID since 9 Mar 2018 (UDI-DI 05903293141120), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5903293141760000CZ Basic UDI-DI 05903293141120UDI-DIDate24 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05903293141120 UDI-DI Date9 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5903293141760000CZ registered 24 Jun 2022 Active
  • FDA GUDID UDI-DI 05903293141120 listed 9 Mar 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05903293141120
  2. Registered EUDAMED 5903293141760000CZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pts 920 EUDAMED
Automated Perimeter GUDID
Generic name
Perimeter, automatic
Model / Ref / Catalog
REF 760-001 EUDAMED
PTS 920 GUDID
760-001 GUDID
Primary DI / UDI-DI
05903293141120
Basic UDI-DI
5903293141760000CZ
FDA product code
HPT
EMDN code
Z1212012003 Peripheral vision analysers
GMDN term
Perimeter, automatic
Device class
Class I
Regulation number
886.1605
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
REF 760-001
GUDID
PTS 920

Manufacturer details

EUDAMED SRN
PL-MF-000004770

Related devices

Category: Perimeter, automatic

Similar devices in this category

Other devices filed under PERIPHERAL VISION ANALYSERS.

Other devices from Optopol Technology Sp Z O O

See all devices from Optopol Technology Sp Z O O →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)