Organization name

Siare Enginnering International Group S.p.A.

SRN

IT-MF-000025581

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  Ensure that operators are adequately trained to use the device. Provide detailed instructions for use and maintenance.

• Caution

  Establish a schedule for maintenance and inspection of the device.

Primary placement in Italy; available across 32 countries total.

Trade name

CAP 700

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.

08033737268407

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.

80337372684QM

Reference / catalog number

980700

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 IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The CAP 700 is a cough stimulator can be used on adult, child and newborn patients.

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.

• Z12030103PULMONARY VENTILATORS FOR NON–HOSPITAL USE

• Class IIb medical devices in EUDAMED

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