SARAH Platform

Organization name

SAVENTIC HEALTH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

SRN

PL-MF-000021889

Manufacturer status

Active

Primary placement in Poland; available across 2 countries total.

Trade name

SARAH Platform

UDI-DI code

D-PL-MF-000021889BG

Basic UDI-DI

B-PL-MF-000021889BG

Reference / catalog number

N/A

Issuing entity

EUDAMED

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The SARAH Platform is a software as a computational platform include hardware and software resources (data mining tool which includes algorithms). The SARAH Platform is intended by Saventic Health Sp. z o.o., to be used, isolated for investigation physiological state patient base on the laboratory test results and algorithms used the in computational platform. The data mining tool which includes algorithms automatic analyze the laboratory test results and providing screening tests and information about early diagnosis of rare and ultra-rare disease. The data mining tool provides the medical professional user (doctor) with access to the interpretation of patient test results, screening tests and diagnosis of rare and ultra rare diseases. The data mining tool uses data from laboratory tests that support patient screening and the process of early diagnosis of rare and ultra rare diseases.

Additional information URL

https://www.saventic.com/_files/ugd/516f3e_5b82700b78314956ad2f4177d9656487.pdf

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-PL-MF-000021889BG

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

This device is not currently linked to any other device.