Organization name

Cardionovum GmbH

SRN

DE-MF-000005316

Manufacturer status

Active

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

• Consult instructions for use
• Contains a medicinal substance
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date

Primary placement in Germany; available across 32 countries total.

Trade name

RESTORE PLUS DCB

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.

05906190154088

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.

B-05906190154088

Reference / catalog number

RP 2.00-25

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 III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2 MU50
• 25 MU50

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

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

• C010401020101PTCA BALLOON DILATION CATHETERS

• Class III medical devices in EUDAMED

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