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

1731SGD — Class I MDR by ORTOTEX MEDICAL S.L.

MD Atlas
ORTOTEX MEDICAL S.L.

EUDAMED last updated this device on Mar 18, 2025

1731SGD

843702443305CQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOTEX MEDICAL S.L.
UDI-DI code: 08437024433460
Reference / catalog number: 1731SGD

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: 08437024433460
Basic UDI-DI: 843702443305CQ
Reference / catalog number: 1731SGD
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 Lambskin anti-bedsore boot ORTOTEX MEDICAL has the following main properties: Chrome-free, tanned with natural products that do not irritate the skin. Fire-resistant function. Reduces friction and slippage. Hygroscopic function, absorbs moisture generated by perspiration (approximately 30%). Reduces pressure, promoting proper ventilation of the affected area. Preventive and supportive function. Maintains resistance, density, and softness for a long time. It is indicated for preventing the appearance of pressure ulcers due to restricted blood flow caused by the localized compression of soft tissue arterial networks.
Additional information URL: https://ortotexmedical.com/producto/bota-lambskin/
Clinical sizes: 9 MU10
19 MU10
27 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