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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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Organization name
UDI-DI code
Reference / catalog number

Ophthalmic Unit Comfort Maxi EL — Class I MDR

MD Atlas
POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Sep 22, 2023

Ophthalmic Unit Comfort Maxi EL

5905913529OPTUNIT8S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05905913529196
Reference / catalog number: UN5EL

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View device family (Basic UDI)

Manufacturer information

Organization name: POLAND OPTICAL SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000037042
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement	May 26, 2021	Still on market
Germany	May 26, 2021	Still on market

Device identification

Trade name: Ophthalmic Unit Comfort Maxi EL
UDI-DI code: 05905913529196
Basic UDI-DI: 5905913529OPTUNIT8S
Reference / catalog number: UN5EL
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12129001OPHTHALMOLOGICAL INSTRUMENT STANDS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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