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EUDAMED last updated this device on Jun 2, 2026
426020155FHSCHX8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →ALFA-Flex Shoes/Foot Supports Henry, Sz. 190 R is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Semeda GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →04260201550315Basic 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 →426020155FHSCHX8AL 1411-190-RUDI 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 →(01)04260201550315
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y06120601PASSIVE ANKLE-FOOT ORTHOSESSterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 18 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jun 1, 2009 | Still on market |
| Austria | Feb 24, 2023 | Still on market |
| Belgium | Dec 9, 2016 | Still on market |
| Cyprus | Jun 18, 2024 | Still on market |
| Czechia | Aug 12, 2016 | Still on market |
| Denmark | Aug 12, 2016 | Still on market |
| EL | Oct 30, 2020 | Still on market |
| Spain | Dec 13, 2016 | Still on market |
| Finland | Aug 11, 2016 | Still on market |
| France | Aug 12, 2016 | Still on market |
| Croatia | Feb 17, 2017 | Still on market |
| Italy | Jan 24, 2017 | Still on market |
| Lithuania | Feb 8, 2022 | Still on market |
| Netherlands | Sep 23, 2016 | Still on market |
| Poland | Jun 25, 2018 | Still on market |
| Romania | Jan 13, 2017 | Still on market |
| Sweden | Jan 23, 2017 | Still on market |
| Slovakia | Aug 11, 2016 | Still on market |
DE-MF-000008334No 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.426020155FASZBSXVOn the marketALFA-Flex Brace padding426020155ZBHSP56On the marketALFA-Flex Light Brace Foot Abduction Brace426020155FASZBSXVOn the marketALFA-Flex Shoes/Foot Supports Henry, Sz. 100 L426020155FHSCHX8On the marketALFA-Flex Shoes/Foot Supports Henry, Sz. 100 R426020155FHSCHX8On the market