Organization name

Spex Ltd

SRN

NZ-MF-000009327

Manufacturer status

Active

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

• Consult instructions for use

  To avoid injury, read, understand and follow all instructions and warnings before installing and using the Spex Medial Thigh Support

Primary placement in Germany; available across 32 countries total.

Trade name

Spex

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.

09420082647268

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.

94200517MEDTHIGHSZ

Reference / catalog number

1162-1710-000

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

Lock Pin Block Assembly complete with pin

Additional information URL

https://www.spexseating.com/user-manuals/

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.

• Y122499WHEELCHAIRS ACCESSORIES - OTHER

• Class I medical devices in EUDAMED

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