Organization name

Evac Chair North America LLC

SRN

US-MF-000055919

Manufacturer status

Active

Primary placement in Spain; available across 32 countries total.

Trade name

EVAC+CHAIR 700H

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.

05061044590280

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.

506104459ECNAMANUALJT

Reference / catalog number

1-700H

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

An evacuation chair designed for use during an emergency situation to assist with evacuating a premises.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Y1899AIDS, FURNITURE AND HOME AIDS FOR PERSONS WITH DISABILITIES - OTHER

• Class I medical devices in EUDAMED

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