Organization name

SIEM NOVA SRL

SRN

IT-MF-000034107

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

not provided

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.

08053435660204

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.

B-08053435660204

Reference / catalog number

66130

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 IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Model 6110-A3 SIEM is an extraordinarily powerful surgical aspirator designed for tracheal and bronchial aspiration. Significant amounts of secretions and serous fluids, including particles contained in them can be suctioned quickly from natural body cavities and artificial openings.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 60 MU999

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

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

• Z120105SURGICAL MEDICAL ASPIRATORS

• Class IIa medical devices in EUDAMED

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