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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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FluoBolt™- MEF Analytics Plattform — 2 UDI-DI variants, IVDR

MD Atlas
FIANOSTICS GmbH

Data from EUDAMED, last updated May 23, 2026

FluoBolt™- MEF Analytics Plattform

PP10748W0201029962

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: FIANOSTICS GmbH

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: PP10748W0201029962
Device name: FluoBolt™- MEF Analytics Plattform
Issuing agency: IFA
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Apr 21, 2023

Manufacturer & authorised representative

Manufacturer

Name: FIANOSTICS GmbH
SRN: AT-MF-000025705
Country: Austria
Email: office@fianostics.at
Phone: +43262227514

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GYCSBQZGQN3KSKBGBB1RSA30

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

FluoBolt™ - Metal Enhanced Fluorescence (MEF) Analytics Platform111875634285
FIA-1709111883077184