BrownGuard 2000 ankle orthosis type 01

Organization name

ARIES, a.s.

SRN

CZ-MF-000047385

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  • the ankle orthosis can be machine washed after removing the splints (max. temperature 30 °C, gentle cycle) with a soapy solution or a special detergent for compression stockings and bandages, in a protective cover (washing bag) • always leave the hook-and-loop fasteners fastened when washing • do not use fabric softener • do not use centrifugation, squeeze the wet ankle orthosis between two towels • lay flat to dry, away from a direct heat source (radiator, direct sunlight) • do not iron the ankle orthosis • maximum number of washing cycles is 60 • store in a dark, dry place in the original packaging • do not alter the ankle orthosis in any way, do not repair areas damaged by use, do not trim the edges • keep the ankle orthosis away from organic solvents and bleaching agents

Primary placement in Czechia; available across 1 country total.

Trade name

BrownGuard 2000 ankle orthosis type 01

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08590072849574

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

85900722023032Y

Reference / catalog number

NA

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

A medical device designed to support the ankle during post-traumatic and post-operative therapy, prevent swelling and serve as support for ankle ligament and tendon laxity, inflammation or injury.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 9999
• XXL
• double-sided

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y06120601PASSIVE ANKLE-FOOT ORTHOSES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.