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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

1091.500 P — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Feb 6, 2025

1091.500 P

84355156flsalineacion82

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08430469233442
Reference / catalog number: 1091.500 P

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Manufacturer information

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

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: not provided
UDI-DI code: 08430469233442
Basic UDI-DI: 84355156flsalineacion82
Reference / catalog number: 1091.500 P
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: Postural Alignment Insole, for adults, are indicated for: • Improvement Body Alignment: Contribute to improve the alignment of the body respecting the body’s line of gravity, frontally and laterally. Provide a more adequate posture, helping to prevent overloads and helps relieve joint discomfort in the ankles, knees and hips. • Plantar Structuring: Center the rearfoot to avoid excessive pronation or supination. Limit lateral deviations when walking, reduce the risk of ligament strains and avoid overloads in joints, such as the ankle and knee. • Foot Pressure Distribution: Contribute to the proper distribution of pressures on the foot due to the body’s weight. Distribute the loads between the calcaneus, the plantar arches and the metatarsal area, relieving plantar pain and improving walking comfort.
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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