Organization name

SIEM NOVA SRL

SRN

IT-MF-000034107

Manufacturer status

Active

Primary placement in Italy; available across 32 countries total.

Trade name

VENTOSA OSTETRICA ELETTRICA MOD 6110-A10 VENTOSA-SIEM

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.

08053435660297

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-08053435660297

Reference / catalog number

66200-5L

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-A10 VENTOSA-SIEM is a surgical aspirator and consists of a very reliable suction pump with constant suction, connected via a tube to a metal or silicone cup. Vacuum regulation is done by 4 mechanically operated stages with automatic switching off and on. It is used to accelerate the completion of delivery in case of: delayed head progression due to lack of effectiveness of uterine contractions uncooperative woman in the expulsive period signs of fetal suffering

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 95 LITRI / MINUTO

• 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.