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137 device results listed.

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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

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

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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

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

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

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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

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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

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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

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IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170516
Basic UDI-DI: B-08431673170516
Reference: SP1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170509
Basic UDI-DI: B-08431673170509
Reference: 1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673088422
Basic UDI-DI: B-08431673088422
Reference: JL1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:17

Manufacturer products View details

IgE-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673079314
Basic UDI-DI: B-08431673079314
Reference: MI1107050
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:16

Manufacturer products View details

+ENTIDNOV10204

IgE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV10204
Basic UDI-DI: B-+ENTIDNOV10204
Reference: DNOV102
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:12

Manufacturer products View details

IMMULITE 2000 Total IgE

IVDR_67_LLB_DUB-C_B_KIT_Total IgE

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966083
Basic UDI-DI: 0405686901411V3
Reference: 10380873
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex IgE mono

IVDR_27_MAR EB_B_REAG_N_La_IGE

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768008078
Basic UDI-DI: 0405686900959WH
Reference: 10446129
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

IMMULITE 2000 3g Allergy Specific IgE Universal Kit

IVDR_67_LLB_DUB-C_C_KIT_3g Allergy Spfc IgE Univ Kit

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962269
Basic UDI-DI: 0405686900223UR
Reference: 10380875
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details