Organization name

AKTIVE SRL

SRN

IT-MF-000007813

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  Do not use past indicated expiration date

Primary placement in Italy; available across 32 countries total.

Trade name

Set Bi-Manual I/A Handpieces 21G

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.

08052276026361

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.

8052276FT0001ID7CL

Reference / catalog number

AK-0439

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

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

Status

On the market

Quantity

20

Additional product description

Set Cannule Bimanuali I/A 21G

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 21 gauge

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

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

• Q021101OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE

• Class IIa medical devices in EUDAMED

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