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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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ISE Low Calibrator — 1 UDI-DI variant, IVDR

MD Atlas
Instrumentation Laboratory SpA

Data from EUDAMED, last updated May 30, 2026

ISE Low Calibrator

84269500217595T

1 UDI-DI variant

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: Instrumentation Laboratory SpA

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 84269500217595T
Device name: ISE Low Calibrator
Device model: 0018469200
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Oct 23, 2023

Manufacturer & authorised representative

Manufacturer

Name: Instrumentation Laboratory SpA
SRN: IT-MF-000009277
Country: Italy
Email: nbova@werfen.com
Phone: 02 25221

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01HDE9SY2R4SX00X4FW5Z8534J

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

001846920008426950021759