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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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ImmunoCAP Total IgE — 2 UDI-DI variants, IVDR (Phadia AB)

MD Atlas
Phadia AB

Data from EUDAMED, last updated May 31, 2026

ImmunoCAP Total IgE

7333066BUDI0060LY

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: Phadia AB

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Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

Identity & classification

Basic UDI-DI: 7333066BUDI0060LY
Device name: ImmunoCAP Total IgE
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Mar 25, 2026

Manufacturer & authorised representative

Manufacturer

Name: Phadia AB
SRN: SE-MF-000014170
Country: Sweden
Email: RegulatoryAffairs.Uppsala.IDD@thermofisher.com
Phone: +46 18 165000

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KMJSE33QJ3VK82MD87MEWW4Q

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

ImmunoCAP Total IgE Calibrator Strip07333066019796
ImmunoCAP Total IgE Curve Control Strip07333066019789