KD-PENOFINE

Organization name

KD Medical GmbH Hospital Products

SRN

DE-MF-000006773

Manufacturer status

Active

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

• Caution
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Consult instructions for use

Primary placement in Sweden; available across 13 countries total.

Trade name

KD-PENOFINE

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.

54031881904256

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.

4031881G10-02aIIaUV

Reference / catalog number

904251T

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

Pen needles, 30G, 0,30 x 6 mm, LB, TW

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 54031881904256× 1 unitBase unit
  • 64031881904253× 10,000 units

• 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

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