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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

Hand rehabilitation ball Ergo-Soft — Class I MDR

MD Atlas
Dr Sapporo Hanna Affelt Sp. j.

EUDAMED last updated this device on Oct 31, 2024

Hand rehabilitation ball Ergo-Soft

5908249910BA1BY

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr Sapporo Hanna Affelt Sp. j.
UDI-DI code: 59082499106902
Reference / catalog number: 5908249910690

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View device family (Basic UDI)

Manufacturer information

Organization name: Dr Sapporo Hanna Affelt Sp. j.
SRN: PL-MF-000044757
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 Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Device identification

Trade name: Hand rehabilitation ball Ergo-Soft
UDI-DI code: 59082499106902
Basic UDI-DI: 5908249910BA1BY
Reference / catalog number: 5908249910690
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: A medical device intended for hand rehabilitation exercises. It allows for muscle strengthening, elasticity improvement, and motor coordination. Ideal for therapy after injuries or surgical procedures. Ensures comfortable use and supports the return to full functionality.
Additional information URL: https://drsapporo.com/pileczka-rehabilitacyjna
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)59082499106902

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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.

Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - 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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