Organization name

Infermedica Sp. z o.o.

SRN

PL-MF-000030822

Manufacturer status

Active

Primary placement in Poland; available across 12 countries total.

Trade name

Medical Guidance Platform

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.

05904610848036

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.

5904610848MGPB7

Reference / catalog number

6.5.0

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 IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

MGP is intended to provide information which may be used to make decisions with diagnostic purposes. It is a software system, containing web-application, mobile application and API designed to support the process of an initial medical interview and triage to the right point of medical care.

Additional information URL

https://demo-mgp.infermedica.com/mgp-statics/instructions/mgp/en/instruction.pdf

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.

• V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

• Class IIb medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.