Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

FM5 250 35/36 — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Jun 27, 2025

FM5 250 35/36

84355156FM5250CA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08435515600117
Reference / catalog number: FM5 250 35/36

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: 08435515600117
Basic UDI-DI: 84355156FM5250CA
Reference / catalog number: FM5 250 35/36
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 FM5 250 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. Fabricadas en resina termomoldeable, destacan por su estructuración, resistencia y capacidad para absorber impactos. Están diseñadas para proporcionar confort en el uso diario y son ideales para personas con hiperpresiones en zonas focalizadas.
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

Related devices

DIABEFLEX INSOLE SIZE 35/36843551567500TPRXLOn the market DIABEFLEX INSOLE SIZE 37/38843551567500TPRXLOn the market DIABEFLEX INSOLE SIZE 41/42843551567500TPRXLOn the market DIABEFLEX INSOLE SIZE 43/44843551567500TPRXLOn the market DIABEFLEX INSOLE SIZE 45/46843551567500TPRXLOn 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.