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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

DIABEFLEX INSOLE SIZE 45/46 — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Mar 31, 2025

DIABEFLEX INSOLE SIZE 45/46

843551567500TPRXL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08435515600094
Reference / catalog number: 7500TPR 45/46

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Manufacturer information

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

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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 47/48843551567500TPRXLOn 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.

Critical warnings

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

CW011
No utilizar en caso de dolor sin consultar a un profesional sanitario. La adaptación de la plantilla lleva tiempo: comience con periodos cortos y aumente gradualmente para permitir que el cuerpo se adapte

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: DIABEFLEX INSOLE SIZE 45/46
UDI-DI code: 08435515600094
Basic UDI-DI: 843551567500TPRXL
Reference / catalog number: 7500TPR 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: DIABEFLEX is the new range of insoles specially designed for delicate conditions such as diabetes, geriatrics, or sensitive feet. DIABEFLEX insoles offer the best properties available on the market thanks to the combination of two excellent materials: Lat-air® latex and Poron®, without the use of adhesives, and featuring our Lat-airComplet technology. This ensures the highest benefits
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

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Software identification