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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

Toe spreader-L — Class I MDR by Berkemann Hungary Bt.

MD Atlas
Berkemann Hungary Bt.

EUDAMED last updated this device on Nov 30, 2023

Toe spreader-L

4049261HVS2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Berkemann Hungary Bt.
UDI-DI code: 04049261008703
Reference / catalog number: 508129/002/650-L

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Manufacturer information

Organization name: Berkemann Hungary Bt.
SRN: HU-MF-000007044
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: Toe spreader-L
UDI-DI code: 04049261008703
Basic UDI-DI: 4049261HVS2
Reference / catalog number: 508129/002/650-L
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: 2
Additional product description: The toe spreader made of soft para rubber relieves pain and discomfort between the toes. The para rubber used is food safe, does not contain any silicone oil or latex and is therefore extremely gentle on the skin. The included pin increases the stability in the front of the toe spreader.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

508140/002/9904049261KBLOn the market 508157/002/990 4049261KBLOn the market 508330/002/6504049261TT00YAOn the market 508330/002/6404049261TT00YAOn the market 508330/002/6304049261TT00YAOn 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.