Organization name

Codonics Inc.

SRN

US-MF-000008190

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

Codonics Direct Vista 1417 DVB

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.

10814905020608

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.

081490502DVCVHCM014Y

Reference / catalog number

1417-DVB 500 sheets/Case

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

5

Additional product description

1417-DVB Blue Base Film (500 sheets/5 cassette case)

Additional information URL

https://radiology.codonics.com/MDR/

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.

• Z130106DRY THERMAL PRINTER X-RAY FILMS

• Class I medical devices in EUDAMED

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