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

Dropfoot Textile Orthosis, band ML — Class I MDR by PRIM, S.A.

MD Atlas
PRIM, S.A.

EUDAMED last updated this device on May 18, 2026

Dropfoot Textile Orthosis, band ML

843404825ORTESISTOBILLOTM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PRIM, S.A.
UDI-DI code: 08426680049719
Reference / catalog number: ATX11 ML

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: PRIM, S.A.
SRN: ES-MF-000004651
Manufacturer status: Active

Related devices

AQTIVO Skin Elastic knee brace L843404825ORTESISRODILLASDOn the market AQTIVO Skin Elastic knee brace XL843404825ORTESISRODILLASDOn the market Closure for Milwaukee corset843404825CORSECXOn the market COREX+ Bivalve Corset843404825CORSECXOn the market Pavlik Harness (OP)843404825ORTESISCADERAYTOn 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 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: Dropfoot Textile Orthosis, band ML
UDI-DI code: 08426680049719
Basic UDI-DI: 843404825ORTESISTOBILLOTM
Reference / catalog number: ATX11 ML
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y06120602ENERGY RETURN ANKLE-FOOT ORTHOSES

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