Avicenum ORTHO 360 ankle brace type 02

Organization name

ARIES, a.s.

SRN

CZ-MF-000047385

Manufacturer status

Active

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

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

• CW999

  Prohibited use: Stop using the product immediately if: • if it shows signs of mechanical damage (replace the product) • your health has deteriorated which could be associated with the use of the product – consult your doctor at once Contraindications: • damaged skin • acute weeping skin manifestations • lymphatic swelling • hypersensitivity to materials used • limb sensitivity disorders (e.g., peripheral neuropathy)

Primary placement in Czechia; available across 1 country total.

Trade name

Avicenum ORTHO 360 ankle brace type 02

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.

08590072706785

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.

85900722019053T

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

The medical device designed to support the ankle during post-traumatic and post-operative therapy, to prevent swelling and as a support by weakness, inflammation or injury of ligaments and ankle tendons. This bandage is also suitable for sporting activities as therapeutic or preventive.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• double-sided, figure-of-eight strap
• 8001
• L

• 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