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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

TAKO CAST FEET BOOT — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Feb 12, 2025

TAKO CAST FEET BOOT

84355156TAKO2000V8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08435515601046
Reference / catalog number: 2000 3

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Manufacturer information

Organization name: Flexor S.A.
SRN: ES-MF-000042891
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Evite el uso en superficies irregulares o resbaladizas. • No utilizar para actividades deportivas o de alto impacto. • Consulte siempre a un especialista antes de modificar el ajuste de la bota.

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: TAKO CAST FEET BOOT
UDI-DI code: 08435515601046
Basic UDI-DI: 84355156TAKO2000V8
Reference / catalog number: 2000 3
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: The TAKO is indicated for: • The orthopedic boot TAKO is the evolution to the conventional cast. This boot is elaborated with an anti-slip sole to give security during walking, it performs a rocker sole effect. • The cut allows wrapping the cast or bandaged foot, helping to accelerate the healing and recovery processes of an injury.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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

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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.