Optical tip PRIMO/RAPIDO

Organization name

Medency S.r.l.

SRN

IT-MF-000027255

Manufacturer status

Active

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

• CW010

  -

Primary placement in Italy; available across 10 countries total.

Trade name

Optical tip PRIMO/RAPIDO

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.

08059340290390

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.

805934029MED.TIP.QX

Reference / catalog number

MED-TIP.04

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

5

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 10 MU50
• 400 MU43

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

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

• Z12011085LASER SURGERY INSTRUMENTS - CONSUMABLES

• Class IIa medical devices in EUDAMED

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