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Unicorn-Total IgE

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DT01547E
Basic UDI-DI: B-DT01547E
Reference: DT0154
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

iStar- Total IgE

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76383G8
Basic UDI-DI: B-DC76383G8
Reference: DC76383
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar- Total IgE

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76382G6
Basic UDI-DI: B-DC76382G6
Reference: DC76382
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar- Total IgE

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76381G4
Basic UDI-DI: B-DC76381G4
Reference: DC76381
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Total IgE

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76106FC
Basic UDI-DI: B-DC76106FC
Reference: DC76106
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:04

Manufacturer products Authorised representative products Authorised representative actors View details

iStar- Total IgE

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76104F8
Basic UDI-DI: B-DC76104F8
Reference: DC76104
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:04

Manufacturer products Authorised representative products Authorised representative actors View details

AccuDiag™ Human Specific IgG 88 Food Allergens

Allergy ELISA Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: D-AL5154ZR44EA
Basic UDI-DI: B-AL5154ZR44EA
Reference: 5154-8
EMDN: W01020208
EMDN description: ALLERGENE SPECIFIC IGG
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

AccuDiag™ Human Specific IgE (20 Seasonal Allergens)

Allergy Immunoblot Assay

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Diagnostic Automation/ Cortez Diagnostics, Inc.
Manufacturer SRN: US-MF-000051963
UDI-DI: D-AB5150ZR445Q
Basic UDI-DI: B-AB5150ZR445Q
Reference: 5150-8
EMDN: W01020202
EMDN description: IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 12.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M08FC
Basic UDI-DI: B-7M08FC
Reference: 7M08V1-B-EU, 7M08U1-B-EU, 7M08P1-B-EU
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474620QQ
Basic UDI-DI: B-474620QQ
Reference: 474620
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

Bioeurope 14 Food Intolerance Test (ref:7194)

7194

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: 42623675671946
Basic UDI-DI: B-42623675671946
Reference: 7194
EMDN: W01020208
EMDN description: ALLERGENE SPECIFIC IGG
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:36

Manufacturer products View details

Bioeurope 7 Food Intolerance Test (ref:7189)

7189

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: 42623675671892
Basic UDI-DI: B-42623675671892
Reference: 7189
EMDN: W01020208
EMDN description: ALLERGENE SPECIFIC IGG
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:36

Manufacturer products View details

Bioeurope 42 Food Intolerance Test (ref:7179)

7179

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: 42623675671793
Basic UDI-DI: B-42623675671793
Reference: 7179
EMDN: W01020208
EMDN description: ALLERGENE SPECIFIC IGG
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:36

Manufacturer products View details

PEO WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277936012B
Basic UDI-DI: B-37700277936012B
Reference: PEO-WB96G
EMDN: W01020299
EMDN description: ALLERGY TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

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PEO WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779359539
Basic UDI-DI: B-377002779359539
Reference: PEO-WB24G
EMDN: W01020299
EMDN description: ALLERGY TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details

PEO WB IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277935883C
Basic UDI-DI: B-37700277935883C
Reference: PEO-WB12G
EMDN: W01020299
EMDN description: ALLERGY TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details

PEO ICT IgG-IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-377002779339733
Basic UDI-DI: B-377002779339733
Reference: MPEO Ab ICT100
EMDN: W01020299
EMDN description: ALLERGY TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:57

Manufacturer products View details

PEO ICT IgG-IgM

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: LDBIO DIAGNOSTICS
Manufacturer SRN: FR-MF-000021697
UDI-DI: D-37700277933802J
Basic UDI-DI: B-37700277933802J
Reference: MPEO Ab ICT20
EMDN: W01020299
EMDN description: ALLERGY TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:56

Manufacturer products View details

D-3073AF

Total IgE in vitro diagnostic kit (Chemiluminescent immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3073AF
Basic UDI-DI: B-3073AF
Reference: AKBR3073030
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

09120122920251

IVD Class CNot specifiedOn the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MacroArray Diagnostics
Manufacturer SRN: AT-MF-000030541
UDI-DI: 09120122920251
Basic UDI-DI: 91201229202JQ
Reference: 02-5001-01
EMDN: W01020205
EMDN description: IMMUNOGLOBULIN E - SCREEN
First on market country: -
Safety summary (SSCP/SSP): TD-9_ALEX² - Summary of Safety and Performance (SSP)_v1.0 · Rev. v1.0
Authorised representative: -
Last updated: 11.07.2026 15:57

Manufacturer products Open in EUDAMED View details