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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

LAB50 FL — IVDR Class A IVDR by OPTA-TECH Sp. z o.o.

MD Atlas
OPTA-TECH Sp. z o.o.

EUDAMED last updated this device on Nov 18, 2025

LAB50 FL

5905817273LAB504S

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: OPTA-TECH Sp. z o.o.
UDI-DI code: 05905817273140
Reference / catalog number: LAB50 FL

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View device family (Basic UDI)

Manufacturer information

Organization name: OPTA-TECH Sp. z o.o.
SRN: PL-MF-000050182
Manufacturer status: Active

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LAB40 FL5905817273LAB404POn the market LAB40 MULTI5905817273LAB404POn the market LAB50 MULTI5905817273LAB504SOn the market MB2005905817273MB2002JOn the market MB200 FL5905817273MB2002JOn the market

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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05905817273140
Basic UDI-DI: 5905817273LAB504S
Reference / catalog number: LAB50 FL
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic 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

UDI-DI DataMatrix

Encoded

(01)05905817273140

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0202050303OPTICAL LABORATORY MICROSCOPES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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