Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

45610 — Class I MDR by Künzli SwissSchuh AG

MD Atlas
Künzli SwissSchuh AG

EUDAMED last updated this device on Aug 6, 2025

45610

76300428AchillesschuheLS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Künzli SwissSchuh AG
UDI-DI code: 07630042809434
Reference / catalog number: 45610

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Künzli SwissSchuh AG
SRN: CH-MF-000044954
Manufacturer status: Active

Related devices

4059376300428Stabilschuhe5MOn the market 4059376300428Stabilschuhe5MOn the market 4059376300428Stabilschuhe5MOn the market 4059376300428Stabilschuhe5MOn the market 4059376300428Stabilschuhe5MOn 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.

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: 07630042809434
Basic UDI-DI: 76300428AchillesschuheLS
Reference / catalog number: 45610
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® Rehab Total ist ein hochfunktioneller Stabilschuh zur Entlastung der Achillessehne und Stabilisierung von Fuss und Sprunggelenk. Durch individuell einlegbare Keile wird eine ca. 30°-Spitzfussstellung erreicht, wodurch der Zug auf die Achillessehne deutlich reduziert wird. Der bequeme Vorder- und Hintereinstieg sowie das Kombi-Verschluss-System mit Klett und Fixschnürung ermöglichen einen sicheren, komfortablen Sitz. Der Schuh ist orthopädisch zurichtbar und fördert eine frühfunktionelle Mobilisation im Rehabilitationsverlauf.
Additional information URL: https://www.kuenzli-schuhe.ch/ortho_standardschuhe/Ortho-Rehab-Total-45610
Clinical sizes: 6 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
Serial number
Software identification