Organization name

Curan Medical BV

SRN

NL-MF-000022827

Manufacturer status

Active

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

• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Refer to instruction manual/booklet

Primary placement in Netherlands; available across 17 countries total.

Trade name

TPU Curan Hydrophilic Coated

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.

08718657211978

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.

871865721TPU-THC8H

Reference / catalog number

THM16

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

TPU Curan Hydrophilic Coated Male Ch16 with Blue Grip non touch device

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5.3 mm

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

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

• U01010502NELATON CATHETERS, NON SELF-LUBRICATING

• Class I medical devices in EUDAMED

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