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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

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

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Apr 16, 2025

819

843702443303CL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433255
Reference / catalog number: 819

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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: 08437024433255
Basic UDI-DI: 843702443303CL
Reference / catalog number: 819
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 anti-mite mattress covers are made from a hypoallergenic and breathable fabric that allows water vapor to pass through (Side A) while acting as an impenetrable barrier to mites, bacteria, and other allergenic components of household dust (Side B). This provides a dual action against mites: effectively isolating them and preventing the deposition of skin cells on the mattress, as these cells are a key source of food. Ortotex hypoallergenic fabrics are coated with the latest generations of breathable polyurethane, specially formulated to meet anti-allergy and antibacterial needs. Additionally, they offer ecological advantages as they do not contain PVC in their composition.
Additional information URL: https://ortotexmedical.com/producto/funda-colchon-antiacaros/
Clinical sizes: 150 MU10
180–200 MU10

EMDN nomenclature code(s)

T030502BED AND STRETCHER HYGIENIC COVERS

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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