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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

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

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Aug 30, 2024

328

843702438801DZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024388456
Reference / catalog number: 328

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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: 08437024388456
Basic UDI-DI: 843702438801DZ
Reference / catalog number: 328
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 "confort and easy cleaning" polyurethane cushion line by ORTOTEX MEDICAL S.L. is designed to prevent and support the treatment of pressure sores, fistulas, postpartum recovery, or pressure ulcers caused by immobility in individuals who must remain seated or in a static position for extended periods.
Additional information URL: https://ortotexmedical.com/producto/cojin-poliuretano-cuadrado-agujero/
Clinical sizes: 11.5 MU10
42 MU10
45 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

Batch number
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Manufacturing date
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