Organization name

Sumed International (UK) Ltd

SRN

GB-MF-000029110

Manufacturer status

Active

Primary placement in Ireland; available across 32 countries total.

Trade name

Integrity Static Cushion Medium Risk

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.

05055826630899

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.

506016089INTSTATM2

Reference / catalog number

INTM28S1818SF

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

Integrity Static Cushion, Medium Risk, Spacer Fabric Cover

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 46 MU10

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

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

• Y180980SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES

• Class I medical devices in EUDAMED

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