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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-LOW Shield Walker - STD… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Oct 6, 2022

BraceID-LOW Shield Walker - STD Line-Small (36-39)

5404020402anklefootAV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020401406
Reference / catalog number: 12-0008-S

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Manufacturer information

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

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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.

Critical warnings

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

CW011
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
CW010
The brace should only be applied in accordance with the instructions for use.
CW262
The product is intended for single patient use.

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: BraceID-LOW Shield Walker - STD Line-Small (36-39)
UDI-DI code: 05404020401406
Basic UDI-DI: 5404020402anklefootAV
Reference / catalog number: 12-0008-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: 36-39 (EU)

EMDN nomenclature code(s)

Y06120601PASSIVE ANKLE-FOOT 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

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Expiration date
Manufacturing date
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Software identification