- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Aug 26, 2022
5404020402shoulderelbowCABraceID-Clavicle support size Extra Small 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.
0540402040159811-0073-XS(01)05404020401598
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y060624SHOULDER-ELBOW ORTHOSES4 warnings recorded — scroll inside the panel to see all entries.
Precautions • This support is to be fitted by a healthcare professional familiar with the purpose for which it is prescribed. The healthcare professional is responsible for providing guidance to the patient and his/her family or assistants. • If unusual swelling, skin discoloration or discomfort occurs, use should be discontinued and a healthcare professional should be consulted. • Ensure that the support does not interfere with circulation or respiration. Undertake circulatory observation after product application. • Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas.
This support is to be fitted by a healthcare professional familiar with the purpose for which it is prescribed. The healthcare professional is responsible for providing guidance to the patient and his/her family or assistants.
This bandage should only be applied in accordance with the instructions mentioned in the manual.
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 2 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
| Portugal | — | 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 →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-Ankle Wrap Bandage5404020402anklefootAVOn the marketBraceID-Cervical Collar Med Density - Medium (8 cm)5404020402trunkheadce5BOn the marketBraceID-Clavicle support size Large5404020402shoulderelbowCAOn the marketBraceID-Clavicle support size Medium5404020402shoulderelbowCAOn the marketBraceID-Clavicle support size Small5404020402shoulderelbowCAOn the market