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Unit Okulistyczny Comfort Maxi L

by Poland Optical Spółka Z Ograniczoną Odpowiedzialnością EUDAMED

Active European Union

Ref UN5BLModel Ophthalmic Unit Comfort Maxi R

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5905913529OPTUNIT8S Basic UDI-DIDate18 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Ophthalmic Unit
Model / Reference
Ophthalmic Unit Comfort Maxi R, UN5BL
Primary DI / UDI-DI
05905913529097
Basic UDI-DI
5905913529OPTUNIT8S
Direct Marketing DI
05905913529097
EMDN Code
Z12129001 Ophthalmological instrument stands
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000037042

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Properties

Show properties
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No