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EUDAMED last updated this device on Aug 24, 2026
5404020402anklefootAVBraceID-Ankle ID FIX-Medium Left is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Orthobroker. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0540402041058311-0009-ML(01)05404020410583
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y06121201PASSIVE KNEE-ANKLE-FOOT ORTHOSES4 warnings recorded — scroll inside the panel to see all entries.
Contra-Indications • This ankle bandage should not be recommended or worn in case of severe ankle sprains with extreme swelling or in case of fractures. Precautions • This product is side specific. Choose left or right in the correct size via the size table. • The brace should fit snugly and be comfortable without interfering with circulation. • Caution: This product contains natural rubber which may cause allergic reactions for people sensitive to LATEX. • Do not apply the brace directly on open wounds or infected areas. Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas. • If unusual swelling, skin discoloration or discomfort occurs, stop using and consult a healthcare professional.
This brace should only be applied in accordance with the instructions mentioned in the manual.
The product is intended for use by a single patient.
BE-MF-000000331The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Belgium; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
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 →5404020402kneehipFJOn the marketBraceID-20° Knee Immobiliser - 60 cm5404020402kneehipFJOn the marketBraceID-Ankle ID FIX-Large Left5404020402anklefootAVOn the marketBraceID-Ankle ID FIX-Medium Right5404020402anklefootAVOn the marketBraceID-Ankle ID Fix-Small Left5404020402anklefootAVOn the marketBraceID-Ankle ID FIX-Small Right5404020402anklefootAVOn the marketNo 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.