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Organization name
UDI-DI code
Reference / catalog number

45581 — Class I MDR by Künzli SwissSchuh AG

MD Atlas
Künzli SwissSchuh AG

EUDAMED last updated this device on Jul 30, 2025

45581

76300428Stabilschuhe5M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Künzli SwissSchuh AG
UDI-DI code: 07630042807676
Reference / catalog number: 45581

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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: 07630042807676
Basic UDI-DI: 76300428Stabilschuhe5M
Reference / catalog number: 45581
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® Winter ist ein warm gefütterter Stabilschuh zur funktionellen Stabilisierung von Fuss und Sprunggelenk in der kalten Jahreszeit. Der hohe Schaft mit herausnehmbaren, thermoverformbaren Stabilisatoren bietet gezielten Halt, während Fersenriemen und elastisches Vorfussband für zusätzliche Sicherheit und Komfort sorgen. Die Schnürung mit Haken und Ösen ermöglicht eine präzise Anpassung. Die rutschfeste Wintersohle mit Gummi-Kork Mischung und das schmutzabweisende Obermaterial machen den Schuh ideal für den Einsatz bei Schnee, Kälte und Nässe.
Additional information URL: https://www.kuenzli-schuhe.ch/ortho_standardschuhe/Ortho-Winter-45581
Clinical sizes: 9.5 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

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Expiration date
Manufacturing date
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Software identification