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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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SensiQuant Direct AML1-ETO MasterMix — 1 UDI-DI variant, IVDD

MD Atlas
BIOCLARMA S.R.L.

Data from EUDAMED, last updated May 31, 2026

SensiQuant Direct AML1-ETO MasterMix

B-08057723370455

1 UDI-DI variant

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]IVDD — General

Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Manufacturer: BIOCLARMA S.R.L.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: B-08057723370455
Device name: SensiQuant Direct AML1-ETO MasterMix
Issuing agency: EUDAMED
Legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk class: IVDD — General
Version date: May 21, 2025

Manufacturer & authorised representative

Manufacturer

Name: BIOCLARMA S.R.L.
SRN: IT-MF-000030384
Country: Italy
Email: davide.barberio@bioclarma.com
Phone: +39 011 18894474

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01JVSQG5ZW14V57NJFAEXRQQE5

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

SQTd-03708057723370455