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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

04262373130005 — Class I MDR by GetSteps GmbH

MD Atlas
GetSteps GmbH

EUDAMED last updated this device on May 11, 2022

04262373130005

426237313SteptrackRH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GetSteps GmbH
UDI-DI code: 04262373130005
Reference / catalog number: 04262373130005

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Manufacturer information

Organization name: GetSteps GmbH
SRN: DE-MF-000022942
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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: not provided
UDI-DI code: 04262373130005
Basic UDI-DI: 426237313SteptrackRH
Reference / catalog number: 04262373130005
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: Steptrack is a medical device designed by the manufacturer to support remote diagnosis of podiatric anomalies, medical analysis of plantar pressure distribution and measurement of the foot (length and width) by means of a static or dynamic footprint.
Additional information URL: https://get-steps.com/pages/so-gehts
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0399MEASUREMENT 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

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.