Organization name

UAB "Ortho Baltic"

SRN

LT-MF-000016954

Manufacturer status

Active

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

• Consult instructions for use

  e-IfU - 2.5 Contraindications

Primary placement in Lithuania; available across 32 countries total.

Trade name

Easy Walk® Eco AFO, Right Large (RL)

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.

04779032101035

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.

477903210EWAFO10ESX

Reference / catalog number

AFO10E=RL

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

Intended purpose: for foot drop condition. The device optimizes the toe lift due to the energy return during the gait cycle.

Additional information URL

https://www.orthobaltic.eu/about-us/downloads.html

Clinical sizes

• Large
• Right

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

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

• Y06120602ENERGY RETURN ANKLE-FOOT ORTHOSES

• Class I medical devices in EUDAMED

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