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Organization name
UDI-DI code
Reference / catalog number

DC15729 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Sep 24, 2024

DC15729

843702443301CG

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433903
Reference / catalog number: DC15729

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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: 08437024433903
Basic UDI-DI: 843702443301CG
Reference / catalog number: DC15729
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 visco two-layer cushions are composed of two layers: the upper layer made of viscoelastic foam and the lower layer made of high-density polyurethane foam. These two components provide comfort and optimal support for the user. The polyurethane cover is breathable, fire-resistant, waterproof, etc.
Additional information URL: https://ortotexmedical.com/producto/cojin-visco-dos-compuestos-herradura/
Clinical sizes: 8 MU10
42 MU10
42 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
Expiration date
Manufacturing date
Serial number
Software identification