Organization name

DeRoyal Industries, Inc.

SRN

US-MF-000002102

Manufacturer status

Active

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

• Caution

  Consult instructions for use

Primary placement in Netherlands; available across 32 countries total.

Trade name

Ankle Contracture Boot

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.

00749756142083

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.

074975612510553

Reference / catalog number

4300C

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

Ankle Contracture Boot, Vel-Foam with Sole & Extra Liner

Additional information URL

https://www.deroyal.com/

Clinical sizes

• 0 MU162

• 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.