Organization name

Shannon Electronics

SRN

NL-MF-000001542

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

SPA Main Switch Unit

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.

08720299497528

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.

87202994975SPAMainKW

Reference / catalog number

SPA Main Switch Unit

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

The Shannon SPA (Sip and Puff Alternative) is an alternative for the widely used sip and puff switches. These devices are commonly used to activate two switch functions; one by sipping and the other by puffing. They are used in alarm systems, for calling assistance, environmental control, computer access, and more. Standard Sip and Puff switches use tubes or straws and membrane chambers where saliva and other fluids can build up during use. They have to be cleaned often to remain hygienic and require maintenance for reliable operation. When used by different people, they need interchangeable parts or thorough cleaning and disinfection. Also, they cannot be used by people on a respirator. The SPA system comprises a main switch unit and a sensor of choice. Several types of touch or proximity sensors are available and they can be exchanged easily. There is almost always a solution possible to control the SPA with fingers, head, chin, foot, lips or other body parts.

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.

• Y210905EXTERNAL SENSOR INTERFACES

• Class I medical devices in EUDAMED

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