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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-ORT-204-43 — Class I MDR by VAYA Spółka z…

MD Atlas
VAYA Spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on May 20, 2025

VAYA-ORT-204-43

5903111FLATFEETSG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VAYA Spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05904473792088
Reference / catalog number: VAYA-ORT-204-43

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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: 05904473792088
Basic UDI-DI: 5903111FLATFEETSG
Reference / catalog number: VAYA-ORT-204-43
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: 2
Additional product description: 3/4 type insoles for narrow and fitted shoes. They provide comfort for feet with longitudinal and transverse flat feet. They prevent the longitudinal arch from falling, increase the contact surface of the foot with the ground and distribute the load on the feet. Made of soft organic sheepskin.
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)05904473792088

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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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