Organization name

Codonics Inc.

SRN

US-MF-000008190

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

Horizon GS

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.

00814905020106

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.

081490502HZMMI01G9

Reference / catalog number

HZGS

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

1

Additional product description

Codonics Grayscale Desktop Large Format Film and Paper Diagnostic Imager, 3 Media Input

Additional information URL

https://www,codonics.com/

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.

• Z110706VIDEO OR DIGITAL BIOIMAGING PLAYERS

• Class I medical devices in EUDAMED

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