Organization name

Curan Medical BV

SRN

NL-MF-000022827

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 16 countries total.

Trade name

Curan Complete Compact System

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.

08718657214085

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.

871865721PVC-CBQ6

Reference / catalog number

CC12

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

30

Additional product description

PVC Curan Complete Compact Ch12 with Integrated Urinebag 1000 ml and Introducer tip

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.

• U040102KITS WITH DRAINAGE CATHETERS AND INTRODUCERS

• Class I medical devices in EUDAMED

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