Organization name

Ambu A/S

SRN

DK-MF-000001437

Manufacturer status

Active

Primary placement in Denmark; available across 28 countries total.

Trade name

Ambu® Neuroline Monopolar

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.

05707480023714

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.

570748030100804208W

Reference / catalog number

74225-36/40

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

Neurology needle electrodes

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 0.35 MU50
• 25 MU50

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

• 05707480023714× 1 unitBase unit
  • 05707480022946× 40 units
    • 05707480000906× 8 units

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

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

• N010101ELECTROMYOGRAPHIC ELECTRODES

• Class IIa medical devices in EUDAMED

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