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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Ophthalmic Unit — 16 UDI-DI variants, MDR

MD Atlas
POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Data from EUDAMED, last updated May 30, 2026

Ophthalmic Unit

5905913529OPTUNIT8S

16 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 5905913529OPTUNIT8S
Device name: Ophthalmic Unit
Device model: Ophthalmic Unit Comfort Maxi R
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Sep 21, 2023

Manufacturer & authorised representative

Manufacturer

Name: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000037042
Country: Poland
Email: sekretariat@po.pl
Phone: +48 33 851 36 30

Variants by status

UDI-DI variants

16 UDI-DI variants

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Applied filters

basicUdiUlid01HAM0RJM6JCN1760DGXY281NF

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Ophthalmic Unit Comfort L05905913529073
Ophthalmic Unit Comfort Maxi EL05905913529196
Ophthalmic Unit Comfort Maxi ER05905913529202
Ophthalmic Unit Comfort Maxi L05905913529097
Ophthalmic Unit Comfort Plus EL05905913529172
Ophthalmic Unit Comfort Plus ER05905913529189
Ophthalmic Unit Comfort Plus L05905913529080
Ophthalmic Unit Comfort Plus R05905913529035
Ophthalmic Unit Comfort R05905913529028
Ophthalmic Unit ForTis L05905913529233
Ophthalmic Unit ForTis R05905913529226
Ophthalmic Unit Mini L05905913529059
Ophthalmic Unit Mini Plus L05905913529066
Ophthalmic Unit Mini Plus R05905913529011
Ophthalmic Unit Mini R05905913529004
UN5B05905913529042