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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-8101 — Class I MDR by VAYA Spółka z…

MD Atlas
VAYA Spółka z ograniczoną odpowiedzialnością

EUDAMED last updated this device on May 23, 2025

VAYA-8101

5903111BLISTERR5

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VAYA Spółka z ograniczoną odpowiedzialnością
UDI-DI code: 05903111848262
Reference / catalog number: VAYA-8101

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Manufacturer information

Organization name: VAYA Spółka z ograniczoną odpowiedzialnością
SRN: PL-MF-000034726
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: not provided
UDI-DI code: 05903111848262
Basic UDI-DI: 5903111BLISTERR5
Reference / catalog number: VAYA-8101
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: Flexible ultra-thin NEVER SLIP heel clips are made of a new generation of gel (U-GEL) designed to reduce pressure on the back of the heel and absorb micro-shocks occurring in the skeletal system. The heel clips eliminate pain associated with blisters, abrasions and corns. They are transparent and hardly visible. They increase the comfort of wearing shoes and protect sensitive areas, take up little space in the shoe and are very easy to put on.
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

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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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.

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