- Role
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EUDAMED last updated this device on Mar 16, 2026
7071045SupportFootwearT9ME 0939 392346 4,5 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Klaveness Footwear AS. Placed on the EU market in Norway. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
NO-MF-000007972Primary 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 certificate specifically references this device's Basic UDI-DI.
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.(01)07020402215003
The 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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Norway; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| NorwayPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Netherlands | — | Still on market |
| Poland | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07020402215003Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
7071045SupportFootwearT9ME 0939 392346 4,5UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y063303READY-MADE ORTHOTIC SHOES7071045SupportFootwearT9On the marketME 9362 886878717 237071045SupportFootwearT9On the marketME 0986 212 3,57071045SupportFootwearT9On the marketME 9326 980 397071045SupportFootwearT9On the marketME 9370 235212257 387071045SupportFootwearT9On the marketME 9323 886700 267071045SupportFootwearT9On the market