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EUDAMED last updated this device on Mar 6, 2026
4262504384262504380330V9INGA is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by EVERSION Technologies GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
42625043803300INGA - AS - 44(01)42625043803300
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12062602SENSOR-BASED INSOLES1 warning recorded — scroll inside the panel to see all entries.
WARNUNG! In bestimmten Situationen (z. B. hoher Umgebungstemperatur im Sommer, direkte Sonneneinstrahlung) kann sich der Sensor bis auf ca. 51° C erwärmen. Tragen Sie die Sensorsohlen maximal 3 Stunden bei hoher Umgebungstemperatur. Tragen Sie die Sensorsohlen nicht, wenn sie sich ungewöhnlich heiß anfühlen. Verwenden Sie das Produkt nicht bei eingeschränkter Wärme- oder Schmerzempfindung. Wenn sich die Sensorsohlen ungewöhnlich heiß anfühlen oder Sie Rötungen, Schmerzen oder Druckstellen bemerken, entfernen Sie bitte das Produkt sofort aus dem Schuh und kontaktieren Sie den Support. WARNUNG! Die Verwendung dieses Medizinprodukts in unmittelbarer Nähe zu anderen medizinischen elektrischen Geräten (ME-Geräten) oder in gestapelter Anordnung mit solchen Geräten kann zu Fehlfunktionen oder einer Beeinträchtigung der Leistung führen. Warnung! Wenn das Produkt zusammen mit anderen medizinischen elektrischen Geräten als System betrieben wird, liegt die Verantwortung für die Einhaltung der Anforderungen gemäß IEC 60601-1 an ME-Systeme beim Nutzer. WARNUNG! Um mögliche Störungen des Medizinprodukts durch hochfrequente (HF) Kommunikationsgeräte zu vermeiden, sollte ein Mindestabstand von 30cm zwischen tragbaren oder mobilen HFSendern (z. B. Mobiltelefone, WLAN-Router, Walkie-Talkies) und dem Produkt eingehalten werden.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
DE-MF-000048231The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.No certificate specifically references this device's Basic UDI-DI.