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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

Anti-Lea — IVDR Class A IVDR by Farmator spółka z…

MD Atlas
Farmator spółka z ograniczona odpowiedzialnością

EUDAMED last updated this device on Sep 2, 2025

Anti-Lea

59029061850100200BX

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Farmator spółka z ograniczona odpowiedzialnością
UDI-DI code: 05902906185049
Reference / catalog number: 01-002-05

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View device family (Basic UDI)

Manufacturer information

Organization name: Farmator spółka z ograniczona odpowiedzialnością
SRN: PL-MF-000031701
Manufacturer status: Active

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: Anti-Lea
UDI-DI code: 05902906185049
Basic UDI-DI: 59029061850100200BX
Reference / catalog number: 01-002-05
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: Anti-Lea reagents are used for specific, qualitative detection of relevant antigens on erythrocytes and are suitable for tube test. This reagent is intended for professional in vitro use only.
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)05902906185049

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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.

W01030399IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.