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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

Bunion Separator Comfort - toe… — Class I MDR

MD Atlas
Dr Sapporo Hanna Affelt Sp. j.

EUDAMED last updated this device on Nov 4, 2024

Bunion Separator Comfort - toe spreader

5908249910CB1C8

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: 59082499100894
Reference / catalog number: 5908249910089

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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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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: Bunion Separator Comfort - toe spreader
UDI-DI code: 59082499100894
Basic UDI-DI: 5908249910CB1C8
Reference / catalog number: 5908249910089
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: An orthopedic medical device for use in improving toe alignment. It helps separate the big toe from adjacent toes, reducing pain and tension related to bunions. It supports the rehabilitation process and prevents further deformation. The product is recommended for daily use, especially when wearing shoes.
Additional information URL: https://drsapporo.com/separator-na-haluksy-comfort,s
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)59082499100894

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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.

Y0999PERSONAL CARE AIDS - 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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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.