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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

11731PAR — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Feb 28, 2025

11731PAR

843702443305CQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433668
Reference / catalog number: 11731PAR

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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: 08437024433668
Basic UDI-DI: 843702443305CQ
Reference / catalog number: 11731PAR
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: 2
Additional product description: The Lambskin Anti-Bedsore Bootie ORTOTEX MEDICAL has the following main properties: Chromium-free, tanned with natural products that do not irritate the skin. Fire-retardant function. Reduces friction and slippage. Hygroscopic function: absorbs moisture generated by perspiration (approx. 30%). Reduces pressure, promoting proper ventilation of the affected area. Preventive and adjuvant function. Maintains its resistance, density, and softness for a long time. It is indicated to prevent the appearance of pressure ulcers caused by restricted blood flow due to the localized compression of arterial networks in soft tissues.
Additional information URL: https://ortotexmedical.com/producto/patuco-antiescaras-lambskin/
Clinical sizes: 7 MU10
14 MU10
17 MU10

EMDN nomenclature code(s)

V0811HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS

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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