Organization name

Codonics Inc.

SRN

US-MF-000008190

Manufacturer status

Active

Primary placement in Netherlands; available across 32 countries total.

Trade name

SLS 550i

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.

00814905020366

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.

081490502SLSPCS01XR

Reference / catalog number

SLS550i

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

Integrated computer-based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items

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.

• A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

• Class I medical devices in EUDAMED

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