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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

709-1 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Apr 15, 2025

709-1

843702438804E7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024388968
Reference / catalog number: 709-1

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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: 08437024388968
Basic UDI-DI: 843702438804E7
Reference / catalog number: 709-1
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 bed harness is made of a three-layer material (acrylic, foam, and polyester), semi-rigid and breathable. It features adjustable straps and fastening buckles in different colors for easy placement. It also includes a Velcro closure that allows for opening and closing without having to readjust the securing straps. Designed for patients with anterolateral instability and can be adapted to any type of bed.
Additional information URL: https://ortotexmedical.com/producto/arnes-de-cama/
Clinical sizes: 16 MU10
120 MU10

EMDN nomenclature code(s)

V0804PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)

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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