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Organization name
UDI-DI code
Reference / catalog number

5907080634031 — Class I MDR by Si-iS Paweł Wyszyński

MD Atlas
Si-iS Paweł Wyszyński

EUDAMED last updated this device on Oct 22, 2024

5907080634031

5907080634BECZKAKSZTA6F

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Si-iS Paweł Wyszyński
UDI-DI code: 05907080634031
Reference / catalog number: 5907080634031

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View device family (Basic UDI)

Manufacturer information

Organization name: Si-iS Paweł Wyszyński
SRN: PL-MF-000044189
Manufacturer status: Active

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5907097260810590709726BASENE6On the market 5907097260803590709726BASENE6On the market 59070806347895907080634BECZKAKSZTA6FOn the market 59070972600015907080634BECZKAKSZTA6FOn the market 59070806349565907080634BECZKAKSZTA6FOn 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 2 countries total.

Country	On market since	Until
PolandPrimary placement	Jan 2, 2023	Still on market
Czechia	Jan 2, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05907080634031
Basic UDI-DI: 5907080634BECZKAKSZTA6F
Reference / catalog number: 5907080634031
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: Beczka - kształtka to specjalistyczne narzędzie terapeutyczne, zaprojektowane z myślą o osobach z zaburzeniami procesów integracji sensorycznej. Beczka - kształtka przeznaczona jest do pracy z osobami z deficytami w rozwoju reakcji posturalnych, jak również z osobami z niepewnością grawitacyjną w celu stymulacji układu przedsionkowego, kształtowania prawidłowego napięcia mięśniowego ( mięśni brzucha i prostowników grzbietu), w tym odpowiednio wspomaga czucie własnego ciała, rozwój koordynacji wzrokowo- ruchowej oraz planowania motorycznego. Służy rozwijaniu i usprawnianiu układu przedsionkowego, proprioceptywnego oraz zmysłu dotyku. Beczka - kształtka może także być zastosowana w pracy z osobami do ćwiczeń w aspekcie profilaktycznym, wspomagającym prawidłowy rozwój człowieka.
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)05907080634031

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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.

Y0599LEARNING AND TRAINING DEVICES - OTHER

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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