Contrast Booster

Organization name

ulrich GmbH & Co. KG

SRN

DE-MF-000006411

Manufacturer status

Active

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

• Caution
• Consult instructions for use
• Do not re-use
• Do not use if package is damaged
• Type B applied part

Primary placement in Germany; available across 10 countries total.

Trade name

Contrast Booster

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.

04052536203499

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.

4052536000221PW

Reference / catalog number

XD 12600

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

50

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• Z11030580RADIOLOGY INSTRUMENTS - HARDWARE ACCESSORIES

• Class I medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.