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Organization name
UDI-DI code
Reference / catalog number

5907097261039 — Class I MDR by Si-iS Paweł Wyszyński

MD Atlas
Si-iS Paweł Wyszyński

EUDAMED last updated this device on Aug 20, 2025

5907097261039

590709726WSKAKANIA62

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Si-iS Paweł Wyszyński
UDI-DI code: 05907097261039
Reference / catalog number: 5907097261039

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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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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 Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Jan 2, 2023	Still on market
Poland	Jan 2, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05907097261039
Basic UDI-DI: 590709726WSKAKANIA62
Reference / catalog number: 5907097261039
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: Worek do skakania, ćwiczeń to specjalistyczne narzędzie terapeutyczne, zaprojektowane z myślą o osobach z zaburzeniami procesów integracji sensorycznej, celem rozwijania sprawności motorycznej. Regularne ćwiczenia z wykorzystaniem worek do skakania, ćwiczeń usprawniają koordynację ruchową, równowagę i stabilizację, poprzez rozwój reakcji posturalnych, wzmacniają mięśnie nóg, rozwijają umiejętność planowania motorycznego. Aktywności podejmowane przy użyciu worka do skakania, ćwiczeń usprawniają układ proprioceptywny, przedsionkowy, a także słuchowy i wzrokowy. Worek do skakania, ćwiczeń jest wykonany z materiału charakteryzującego się zwiększoną odpornością na uszkodzenia mechaniczne, w tym przetarcia i rozdarcia. Wyrób przeznaczony jest do użytku jednoosobowego.
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)05907097261039

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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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