- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Sep 30, 2022
5404020402anklefootAVBraceID-High Shield Walker - STD Liner-Small (36-39) 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.
0540402040132112-0006-S(01)05404020401321
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y06120601PASSIVE ANKLE-FOOT ORTHOSES3 warnings recorded — scroll inside the panel to see all entries.
Contraindications • Not intended for unstable fractures or fractures of the proximal tibia or fibula Precautions & Warnings • This device should be prescribed by a qualified health care professional who also determines frequency and duration of use. • It should not be prescribed for patients with impaired sensations. • Do not over-inflate air chamber nor over-tighten Velcro straps. These may compromise blood circulation and cause significant skin irritation, especially if used for people with diabetic neuropathy. Frequently perform circulation checks. In case of any skin discoloration or feelings of discomfort, deflate air chamber to a comfortable level. Consult your health care provider immediately if discomfort persists. • In high altitude conditions, the air chambers will expand beyond optimal level. Adjust the • compression level by deflating the air chambers or loosening the Velcro straps. • Use caution when walking on a slippery or wet surface to avoid injury
The brace should only be applied in accordance with the instructions for use.
The product is intended for single patient use.
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.
Placed on the market in Belgium; per-country availability dates not published.
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 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.5404020402anklefootAVOn the marketBraceID-High Shield Walker - STD Liner-Large (43-46)5404020402anklefootAVOn the marketBraceID-High Shield Walker - STD Liner-Medium (39-43)5404020402anklefootAVOn the marketBraceID-High Shield Walker - STD Liner-XLarge (+46)5404020402anklefootAVOn the marketBraceID-KIDS Walker - Large (27-29)5404020402anklefootAVOn the marketBraceID-KIDS Walker - Small (21-23)5404020402anklefootAVOn the market