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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

FM8 280 45/46 — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Jul 28, 2025

FM8 280 45/46

84355156FM8280D8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08435515600285
Reference / catalog number: FM8 280 45/46

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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
Consulte con un profesional de la salud antes de usar las plantillas si tiene afecciones podológicas graves, como úlceras, deformidades severas o problemas circulatorios. En caso de experimentar irritación, dolor o molestias persistentes, retire las plantillas y consulte a un profesional de la salud. No use las plantillas en calzado inadecuado o que no permita una colocación segura y cómoda. Esto puede comprometer la eficacia del producto y causar incomodidad. Asegúrese de que el calzado utilizado sea lo suficientemente espacioso para permitir el uso de las plantillas sin que cause presión excesiva en el pie.

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: not provided
UDI-DI code: 08435515600285
Basic UDI-DI: 84355156FM8280D8
Reference / catalog number: FM8 280 45/46
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: 2
Additional product description: La plantilla FM8 280 está dentro de la gama FLEXOR MEDICAL CARE diseñadas para proporcionar soporte, amortiguación, redistribución de presiones y aliviar los puntos de dolor en las patologías más comunes
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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On the market

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.