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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 Calibrator 1 — 2 UDI-DI variants, IVDR

MD Atlas
Thermo Fisher Scientific Oy

Data from EUDAMED, last updated May 23, 2026

ISE Calibrator 1

6438153BU00135BR

2 UDI-DI variants

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: Thermo Fisher Scientific Oy

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 6438153BU00135BR
Device name: ISE Calibrator 1
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Nov 14, 2023

Manufacturer & authorised representative

Manufacturer

Name: Thermo Fisher Scientific Oy
SRN: FI-MF-000001479
Country: Finland
Email: registrations.clinical.fi@thermofisher.com
Phone: +358 10 329 200

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01HF4K9G2VR8K7EPHE7SHE7H4T

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

INDIKO ISE Calibrator 116438153004070
ISE Calibrator 116438153840319