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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

9001-bz-xs — Class I MDR by MEK-ORTO Sp. z o.o.

MD Atlas
MEK-ORTO Sp. z o.o.

EUDAMED last updated this device on Apr 30, 2026

9001-bz-xs

590464771900176

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEK-ORTO Sp. z o.o.
UDI-DI code: 05904647710436
Reference / catalog number: 9001-bz-xs

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View device family (Basic UDI)

Manufacturer information

Organization name: MEK-ORTO Sp. z o.o.
SRN: PL-MF-000019251
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

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Feb 20, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904647710436
Basic UDI-DI: 590464771900176
Reference / catalog number: 9001-bz-xs
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: Stabilization of ankle / foot joint
Additional information URL: https://mekorto.pl/pl/p/file/29e354f45a6351625f74093d83fb26ed/Instrukcja-uzywania-9001.pdf
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.

Y06120601PASSIVE ANKLE-FOOT ORTHOSES

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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