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Organization name
UDI-DI code
Reference / catalog number

23761 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Sep 17, 2024

23761

843702443301CG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433774
Reference / catalog number: 23761

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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: 08437024433774
Basic UDI-DI: 843702443301CG
Reference / catalog number: 23761
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 intelligent visco gel cushion line features an anatomical design. The viscoelastic foam combined with the polyurethane gel layer provides excellent support for the ischial bones. This allows for reduced fatigue in the area and promotes airflow. The thermal conductivity of the gel helps disperse heat, which is enhanced by the breathable bi-elastic polyurethane cover.
Additional information URL: https://ortotexmedical.com/producto/cojin-visco-gel-inteligente-herradura/
Clinical sizes: 5 MU10
43 MU10
43 MU10

EMDN nomenclature code(s)

V08030102NON-ACTIVE ANTI-DECUBITUS 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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