Organization name

Pikdare S.p.A.

SRN

IT-MF-000010069

Manufacturer status

Active

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

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 27 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.

18058090007439

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.

8058090PN310000ES

Reference / catalog number

02002261000000

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

1

Additional product description

PN31

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 32 MU50
• 4 MU50

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

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

• A0101010202HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.