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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 -Embrace Wrist - XLarge… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Aug 22, 2022

BraceID -Embrace Wrist - XLarge Right

5404020402wristhandZ6

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020402731
Reference / catalog number: 11-0040-XLR

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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
If unusual swelling, skin discoloration or discomfort occurs, stop using and consult a healthcare professional. The brace should fit snugly and be comfortable without interfering with circulation. Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas. The product is intended for single patient use. Contraindications • Severe sprains. • Immediate treatment following fractures
CW030
EUDAMED did not publish a description for this code.
CW010
This 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
EL		Still on market
Poland		Still on market

Device identification

Trade name: BraceID -Embrace Wrist - XLarge Right
UDI-DI code: 05404020402731
Basic UDI-DI: 5404020402wristhandZ6
Reference / catalog number: 11-0040-XLR
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: X-LARGE RIGHT= 20-23 cm

EMDN nomenclature code(s)

Y060612WRIST-HAND 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