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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-Tri-Step Ankle… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Sep 30, 2022

BraceID-Tri-Step Ankle Lace-Up-Large

5404020402anklefootAV

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020400102
Reference / catalog number: 11-0008-L

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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
• Do not apply the brace directly on open wounds or infected areas. • If any problem occurs during use of this bandage, please contact your medical professional.
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 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Poland		Still on market

Device identification

Trade name: BraceID-Tri-Step Ankle Lace-Up-Large
UDI-DI code: 05404020400102
Basic UDI-DI: 5404020402anklefootAV
Reference / catalog number: 11-0008-L
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: Large= 33 - 35,5 cm

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

Batch number
Expiration date
Manufacturing date
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Software identification