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Organization name
UDI-DI code
Reference / catalog number

40595 — Class I MDR by Künzli SwissSchuh AG

MD Atlas
Künzli SwissSchuh AG

EUDAMED last updated this device on Jul 18, 2025

40595

76300428Stabilschuhe5M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Künzli SwissSchuh AG
UDI-DI code: 07630042806013
Reference / catalog number: 40595

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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: 07630042806013
Basic UDI-DI: 76300428Stabilschuhe5M
Reference / catalog number: 40595
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® Stabilschuh ist ein orthopädisches Hilfsmittel zur funktionellen Stabilisierung des Fusses und Sprunggelenks bei Bandläsionen, Instabilitäten sowie chronischen Beschwerden. Er ermöglicht eine kontrollierte frühfunktionelle Mobilisation im Alltag und bei moderater körperlicher Aktivität. Die integrierten, individuell anpassbaren Stabilisatoren fördern die mechanische Führung und sichern die physiologische Bewegung.
Additional information URL: https://www.kuenzli-schuhe.ch/ortho_standardschuhe/Ortho-Sportive-40595
Clinical sizes: 11 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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