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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

45127 — Class I MDR by Künzli SwissSchuh AG

MD Atlas
Künzli SwissSchuh AG

EUDAMED last updated this device on Aug 4, 2025

45127

76300428Stabilschuhe5M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Künzli SwissSchuh AG
UDI-DI code: 07630042806563
Reference / catalog number: 45127

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Manufacturer information

Organization name: Künzli SwissSchuh AG
SRN: CH-MF-000044954
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

1 warning recorded — scroll inside the panel to see all entries.

CW010
Gebrauchsanweisung beachten und die Anweisungen des Arztes befolgen

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: 07630042806563
Basic UDI-DI: 76300428Stabilschuhe5M
Reference / catalog number: 45127
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: Der Künzli Ortho® Rocky Stahl ist ein robuster Arbeits-Stabilschuh mit integrierter Stahlkappe zur Stabilisierung von Sprunggelenk bei hoher Belastung. Der hohe Schaft mit herausnehmbaren, thermoverformbaren Stabilisatoren und seitlicher Verstärkung bietet sicheren Halt im Arbeitsalltag. Die öl- und benzinfeste Schalensohle sowie die Schnürung mit Haken und D-Rings sorgen für Trittsicherheit und festen Sitz. Der Schuh ist orthopädisch zurichtbar und für den Einsatz in anspruchsvollen Arbeitsumgebungen geeignet.
Additional information URL: https://www.kuenzli-schuhe.ch/kuenzli_webshop/Rocky-Stahl-45127
Clinical sizes: 43 MU999

EMDN nomenclature code(s)

Y063303READY-MADE ORTHOTIC SHOES

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
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Software identification