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Organization name
UDI-DI code
Reference / catalog number

11770 — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Sep 10, 2024

11770

843702438801DZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024388616
Reference / catalog number: 11770

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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: 08437024388616
Basic UDI-DI: 843702438801DZ
Reference / catalog number: 11770
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 coccyx wedge cushion is perfect for relieving lower back and leg pain, providing a more correct and upright posture. Its wedge design tilts the pelvis forward, helping to position the spine correctly, reducing pressure on the lumbar area and improving blood circulation. It features a cut-out at the back, allowing the coccyx to be free from any pressure, thereby avoiding the pain and discomfort that can occur when sitting for long periods.
Additional information URL: https://ortotexmedical.com/producto/cojin-poliuretano-cuna-para-coxis/
Clinical sizes: 7 MU10
37 MU10
43 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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