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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- Double-Cross Back… — Class I MDR by Orthobroker

MD Atlas
Orthobroker

EUDAMED last updated this device on Aug 25, 2022

BraceID- Double-Cross Back Support - XLarge

5404020402trunkheadce5B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Orthobroker
UDI-DI code: 05404020401055
Reference / catalog number: 11-0082-XL

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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
Contra Indications • Severe back injuries • Patients known to be sensitised to natural rubber Precautions • The support should fit snugly and comfortably without interfering with respiration. • If discomfort occurs, use should be discontinued and a healthcare professional consulted. • This product contains natural rubber, which may cause allergic reactions • Ensure appropriate wound care procedures are undertaken prior to application over open wounds or infected areas.
CW083
CONTAINS LATEX
CW010
• This brace should only be applied in accordance with the instructions mentioned in the manual.

Market distribution

Primary placement in Belgium; available across 2 countries total.

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

Device identification

Trade name: BraceID- Double-Cross Back Support - XLarge
UDI-DI code: 05404020401055
Basic UDI-DI: 5404020402trunkheadce5B
Reference / catalog number: 11-0082-XL
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 = 112 - 130 cm

EMDN nomenclature code(s)

Y060318CERVICOTHORACOLUMBOSACRAL SPINE 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