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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

26758 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Mar 31, 2026

26758

843661140001CF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08436611400748
Reference / catalog number: 26758

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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.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08436611400748
Basic UDI-DI: 843661140001CF
Reference / catalog number: 26758
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 viscoelastic abductor cushion has a high capacity to conform to the body surface, increasing the contact area between the cushion and the body and absorbing load impact. Its anatomical shape provides comfort, while the abductor block prevents the user from sliding unintentionally.
Additional information URL: https://ortotexmedical.com/producto/cojin-viscoelastico-abductor-antiescaras/
Clinical sizes: 42 MU10
42 MU10
8 MU10

EMDN nomenclature code(s)

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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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