Organization name

Ambu A/S

SRN

DK-MF-000001437

Manufacturer status

Active

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

Primary placement in Denmark; available across 28 countries total.

Trade name

Ambu® aScope 4 Cysto

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.

05707480140558

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.

5707480301005302588

Reference / catalog number

600001000

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

Flexible Cystoscope, Reverse Deflection

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 390 MU50
• 2.2 MU50
• 6 MU50

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

• 05707480140558× 1 unitBase unit
  • 05707480140565× 5 units
    • 05707480140572× 4 units

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

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

• Z12020711VIDEO CYSTOURETHROSCOPES

• Class IIa medical devices in EUDAMED