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09120122920756

ALEX Food

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122920756
Basic UDI-DI: 91201229207K2
Reference: 07-5001-01
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122920657

ALEX Air

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122920657
Basic UDI-DI: 91201229206JY
Reference: 06-5001-01
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122920329

ALEX³ Allergy Xplorer

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122920329
Basic UDI-DI: 91201229203JS
Reference: 03-2001-01
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products View details

09120122920220

ALEX² Allergy Xplorer

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122920220
Basic UDI-DI: 91201229202JQ
Reference: 02-2001-01
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: Austria
Safety summary (SSCP/SSP): TD-9_ALEX² - Summary of Safety and Performance (SSP)_v1.0 · Rev. v1.0
Authorised representative: -
Last updated: 01.08.2026 00:41

Manufacturer products Open in EUDAMED View details

ichroma™ Total IgE

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045473
Basic UDI-DI: 880613300117BR
Reference: CFPC-91
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

tIgE CLIA Microparticles

Autolumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547260
Basic UDI-DI: 697015090000053H5
Reference: CMQ0603
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-020853-00、105-002240-00、105-002241-00、105-020854-00、105-004501-00、105-004502-00、105-002309-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032184
Basic UDI-DI: 69449040004JIgE********W8
Reference: 105-002240-00
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

iMegaFlow-Allergen-sIgE tIgE

Panel A

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912735182
Basic UDI-DI: 692591270296J2
Reference: MF001A1
EMDN: W01020204
EMDN description: IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Total IgE

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719731
Basic UDI-DI: 692591270270HG
Reference: C86285E
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:35

Manufacturer products Authorised representative products Authorised representative actors View details

IgE ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598165113
Basic UDI-DI: B-04050598165113
Reference: K 6511
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IGE

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309175666
Basic UDI-DI: 5204309000029P2
Reference: 1517-0800
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:26

Manufacturer products View details

BioIC Allergen Specific-IgE Detection Kit

AD 40 series/ AP 40 series/ A7A series

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AGNITIO SCIENCE &TECHNOLOGY,INC.
Manufacturer SRN: TW-MF-000040942
UDI-DI: 04719892991155
Basic UDI-DI: 471989299Allergy8G
Reference: AP40
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Total IgE

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026065058
Basic UDI-DI: 357302BUDI000237TB
Reference: 30419
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

EIA Histamine

Immunoassay IM2562

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217785
Basic UDI-DI: 150995905IM256264
Reference: IM2562
EMDN: W01020209
EMDN description: HISTAMINE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

RIA Histamine

Immunoassay IM1659

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590215378
Basic UDI-DI: 150995905IM16596D
Reference: IM1659
EMDN: W01020209
EMDN description: HISTAMINE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227029
Basic UDI-DI: 150995901474620LM
Reference: 474620
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Total Immunoglobulin E (Total IgE) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765545
Basic UDI-DI: B-06971348765545
Reference: MF-53-25
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Total Immunoglobulin E (Total IgE) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760588
Basic UDI-DI: B-06971348760588
Reference: MF-53-20
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673940102
Basic UDI-DI: B-08431673940102
Reference: MD1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:26

Manufacturer products View details

IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673370503
Basic UDI-DI: B-08431673370503
Reference: TK1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:23

Manufacturer products View details