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Organization name
UDI-DI code
Reference / catalog number

1096.500 P — Class I MDR by Flexor S.A.

MD Atlas
Flexor S.A.

EUDAMED last updated this device on Dec 12, 2025

1096.500 P

84355156fascitis1096BR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Flexor S.A.
UDI-DI code: 08430469237747
Reference / catalog number: 1096.500 P

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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
No utilizar el producto en caso de dolor agudo sin consultar a un profesional sanitario. La adaptación a la plantilla puede llevar tiempo: comience con períodos 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: 08430469237747
Basic UDI-DI: 84355156fascitis1096BR
Reference / catalog number: 1096.500 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: Plantar fasciitis insoles for adults are indicated for: *Relief from discomfort associated with plantar fasciitis: Improve the functionality of the plantar fascia, both statically and dynamically. Provide more appropriate biomechanics, helping to prevent overload, reduce stress on the plantar fascia and relieve discomfort in the sole of the foot. *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

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.