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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

GB-BLACK-PVC-65 — Class I MDR by SF SOLUTIONS SPÓŁKA Z…

MD Atlas
SF SOLUTIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

EUDAMED last updated this device on Sep 30, 2025

GB-BLACK-PVC-65

590727436PilkiRehaRY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SF SOLUTIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
UDI-DI code: 05907274362344
Reference / catalog number: GB-BLACK-PVC-65

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View device family (Basic UDI)

Manufacturer information

Organization name: SF SOLUTIONS SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
SRN: PL-MF-000048404
Manufacturer status: Active

Related devices

RB-FB-O-25-35590727436GumyRehaWNOn the market RB-HB-1-27-38590727436GumyRehaWNOn the market RB-PB-P-16-39590727436GumyRehaWNOn the market RB-PB-O-39-104590727436GumyRehaWNOn the market RB-PB-R-7-15590727436GumyRehaWNOn 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: 05907274362344
Basic UDI-DI: 590727436PilkiRehaRY
Reference / catalog number: GB-BLACK-PVC-65
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: Gym Ball 65 cm czarny Gym ball for exercises, Piłka do ćwiczeń, PVC, 55-75 cm, czarny/black
Additional information URL: https://revitymed.pl/
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)05907274362344

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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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