Organization name

Medsynaptic Pvt Ltd

SRN

IN-MF-000051166

Manufacturer status

Active

Primary placement in Ireland; available across 32 countries total.

Trade name

Medsynapse RIS-PACS

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.

09898987000004

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.

0989898700000FL

Reference / catalog number

7.0

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

100

Additional product description

Software based PACS solution is scalable, easy to configure and to use. It is highly customizable to meet various workflows and requirements. It can be used to archive, transfer and visualize the medical images in complex network configurations. The images are compressed in the archive, and they can be easily accessed from the imaging centers, as well as remotely.

Additional information URL

https://medsynaptic.com/service/ris-pacs/

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.

• Z110603PICTURE ARCHIVING AND COMMUNICATION SYSTEMS

• Class I medical devices in EUDAMED

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