Organization name

Malvestio Spa

SRN

IT-MF-000013307

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Using the equipment for purposes other than those described is forbidden (INSTRUCTIONS FOR USE AND MAINTENANCE Intended use). The equipment must only be used by properly trained operator

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.

08058302601540

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.

805830260KOMOBIDX

Reference / catalog number

332490

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

—

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.

• Y1803ASSISTIVE TABLES

• Class I medical devices in EUDAMED

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