Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

755PAR — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Mar 18, 2025

755PAR

843702443305CQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433613
Reference / catalog number: 755PAR

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: ORTOTEX MEDICAL S.L.
SRN: ES-MF-000011654
Manufacturer status: Active

Related devices

721843702438806EBOn the market 723843702438806EBOn the market 816843702438806EBOn the market 11720843702438806EBOn the market 11721843702438806EBOn the market

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: 08437024433613
Basic UDI-DI: 843702443305CQ
Reference / catalog number: 755PAR
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 Ortotex Curved Heel Protector is designed to keep the calcaneus elevated, preventing contact with the mattress, clothing, etc. Helps prevent heel pressure sores. Curved heel protector foam surface: 9 cm wide, 22 cm long, and 13 cm high. Synthetic sheepskin band: 9.5 cm wide and 41.5 cm long, with a Velcro fastening system for leg adjustment. Indicated for the prevention of heel ulcers. Pressure relief is achieved by elevating the heel with a polyurethane foam piece covered with a zippered cotton cover.
Additional information URL: https://ortotexmedical.com/producto/talonera-curva/
Clinical sizes: 9 MU10
13 MU10
22 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification