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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

755 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Mar 18, 2025

755

843702443305CQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433484
Reference / catalog number: 755

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Manufacturer information

Organization name: ORTOTEX MEDICAL S.L.
SRN: ES-MF-000011654
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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437024433484
Basic UDI-DI: 843702443305CQ
Reference / catalog number: 755
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: 1
Additional product description: The Ortotex Curved Heel Protector is designed to keep the calcaneus elevated, preventing contact with the mattress, clothing, etc. Helps prevent heel pressure sores. Curved heel protector foam surface: 9 cm wide, 22 cm long, and 13 cm high. Synthetic sheepskin band: 9.5 cm wide and 41.5 cm long, with a Velcro fastening system for leg adjustment. Indicated for the prevention of heel ulcers. Pressure relief is achieved by elevating the heel with a polyurethane foam piece covered with a zippered cotton cover.
Additional information URL: https://ortotexmedical.com/producto/talonera-curva/
Clinical sizes: 9 MU10
13 MU10
22 MU10

EMDN nomenclature code(s)

V0811HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS

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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