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Organization name
UDI-DI code
Reference / catalog number

15728 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Sep 10, 2024

15728

843702438801DZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024388548
Reference / catalog number: 15728

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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: 08437024388548
Basic UDI-DI: 843702438801DZ
Reference / catalog number: 15728
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 viscoelastic anti-decubitus cushion line is designed for the prevention and relief of body pressure points caused by reduced mobility and prolonged sitting. It also alleviates bodily pressures that help prevent contractures, discomfort, and pain, such as lower back pain, coccydynia, pressure sores, ulcers, among others. In addition, it features diathermic interactive thermosensitivity, which means it adapts to body temperature and responds to changes in environmental temperature.
Additional information URL: https://ortotexmedical.com/producto/cojin-viscoelastica-ranurado/
Clinical sizes: 7.5 MU10
41 MU10
41 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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