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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 Allergen — 42 UDI-DI variants, IVDR (Phadia AB)

MD Atlas
Phadia AB

Data from EUDAMED, last updated May 31, 2026

ImmunoCAP Allergen

7333066BUDI0018LZ

42 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 testing

Identity & classification

Basic UDI-DI: 7333066BUDI0018LZ
Device name: ImmunoCAP Allergen
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

42 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KMJSE7TM3QYA2E5HRFH1K3K8

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 Allergen m3, Aspergillus fumigatus07333066001258
ImmunoCAP Allergen m36, Aspergillus terreus07333066004914
ImmunoCAP Allergen m4, Mucor racemosus07333066001456
ImmunoCAP Allergen m5, Candida albicans07333066001265
ImmunoCAP Allergen m6, Alternaria alternata07333066001135
ImmunoCAP Allergen m7, Botrytis cinerea07333066002521
ImmunoCAP Allergen m8, Setomelanomma rostrata (Helminthosporium halodes)07333066002538
ImmunoCAP Allergen m80, Staphylococcal enterotoxin A07333066004709
ImmunoCAP Allergen m81, Staphylococcal enterotoxin B07333066004716
ImmunoCAP Allergen m9, Fusarium proliferatum07333066002545
ImmunoCAP Allergen mx1, Moulds07333066002019
ImmunoCAP Allergen mx2, Moulds07333066003030
ImmunoCAP Allergen mx4, Moulds07333066004921
ImmunoCAP Allergen rx6, Regional07333066010182
ImmunoCAP Rare Allergen m201, Tilletia tritici (Ustilago tritici)07333066006192
ImmunoCAP Rare Allergen m204, Ulocladium chartarum07333066006178
ImmunoCAP Rare Allergen m226, Staphylococcal enterotoxin TSST07333066009834

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