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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

VAYA-F00042-46 — Class I MDR by VAYA Spółka z…

MD Atlas
VAYA Spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on Feb 9, 2025

VAYA-F00042-46

5903111Opaskizzelem4Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VAYA Spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05904473793399
Reference / catalog number: VAYA-F00042-46

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View device family (Basic UDI)

Manufacturer information

Organization name: VAYA Spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000034726
Manufacturer status: Active

Related devices

VAYA-1015903111NIVELLOWWOn the market VAYA-1025903111NIVELLOWWOn the market VAYA-1281-TC5903111METATARSALVNOn the market VAYA-81115903111HEELSPURUROn the market VAYA-81105903111METATARSALVNOn 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: 05904473793399
Basic UDI-DI: 5903111Opaskizzelem4Y
Reference / catalog number: VAYA-F00042-46
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: Opaska na stopę wykonana z miękkiej, elastycznej i wytrzymałej tkaniny. Poduszka z żelu chroni haluks i śródstopie przed uciskiem, przynosi ulgę w bólu. Redukuje ucisk obuwia na haluks oraz chroni go przed otarciami. Opaska łagodzi uczucie pieczenia przy odciskach, modzelach, nerwiaku Mortona. Redukuje ucisk na śródstopie oraz amortyzuje przy przeciążeniach podczas biegania, dźwigania lub przy nadwadze
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)05904473793399

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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.

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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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