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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

BraceID-Knee support with… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Aug 19, 2022

BraceID-Knee support with HINGE-Small

5404020402kneehipFJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020400232
Reference / catalog number: 11-0022-S

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Manufacturer information

Organization name: Orthobroker
SRN: BE-MF-000000331
Manufacturer status: Active

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Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW011
If unusual swelling, skin discoloration or discomfort occurs, use should be discontinued, and a healthcare professional consulted. Be careful that the support is not so tight that it interferes with circulation. Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas.
CW010
The brace should only be applied in accordance with the instructions mentioned in the manual.

Market distribution

Primary placement in Belgium; available across 3 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Portugal		Still on market
Sweden		Still on market

Device identification

Trade name: BraceID-Knee support with HINGE-Small
UDI-DI code: 05404020400232
Basic UDI-DI: 5404020402kneehipFJ
Reference / catalog number: 11-0022-S
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: measure thigh circumference 15 cm above mid patella. Small= 39-43 cm

EMDN nomenclature code(s)

Y061209KNEE ORTHOSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

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.