Lower-Leg Prosthesis Socket

Organization name

Livit Orthopedie B.V.

SRN

NL-MF-000000548

Manufacturer status

Active

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

• Single patient multiple use

Primary placement in Netherlands; available across 9 countries total.

Trade name

Lower-Leg Prosthesis Socket

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.

08720256363057

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.

8720256363PBOBPKOKERJQ

Reference / catalog number

PB-OBP-KOKER

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

Individualised Lower-Leg Prosthesis Socket

Additional information URL

https://pub.lucidpress.com/producthandleiding-prothesen/

Clinical sizes

No clinical sizes registered for this device.

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

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

• Y062409TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)

• Class I medical devices in EUDAMED

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