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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

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

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Jan 31, 2025

743

843702438807ED

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433545
Reference / catalog number: 743

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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: 08437024433545
Basic UDI-DI: 843702438807ED
Reference / catalog number: 743
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: ORTOTEX Arm Sling: The main function of this type of orthosis for the shoulder, elbow, hand, and wrist is to support and immobilize the upper limb in a specific position. It can be easily put on and removed by the patient without significantly moving the limb. Indicated for soft tissue injuries, rheumatic conditions affecting the shoulder, elbow, or wrist, trauma, postoperative immobilization, etc.
Additional information URL: https://ortotexmedical.com/producto/cabestrillo-sin-inmovilizador/
Clinical sizes: 17 MU10
37 MU10

EMDN nomenclature code(s)

Y060624SHOULDER-ELBOW ORTHOSES

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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