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192 device results listed.

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Evo Total E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155769
Basic UDI-DI: 8058945151N110098ZV
Reference: 1N1100 98
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

Evo Total E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945155752
Basic UDI-DI: 8058945151N110020YQ
Reference: 1N1100 20
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:15

Manufacturer products View details

ImmunoCAP Total IgE Curve Control Strip

ImmunoCAP Total IgE

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019789
Basic UDI-DI: 7333066BUDI0060LY
Reference: 10-9325-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Total IgE Conjugate 100

ImmunoCAP Total IgE

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

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019772
Basic UDI-DI: 7333066BUDI0059MF
Reference: 10-9319-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Total IgE Anti-IgE

ImmunoCAP Total IgE

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066004037
Basic UDI-DI: 7333066BUDI0062M4
Reference: 14-4509-01
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

ImmunoCAP Total IgE Low Range

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066003986
Basic UDI-DI: 7333066BUDI0069MJ
Reference: 14-4497-35
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

06973224897333

30 Tests/kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897333
Basic UDI-DI: 6973224890066AQ
Reference: DC76106
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

IGE

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309086924
Basic UDI-DI: 5204309000029P2
Reference: 1418-0800
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

Total Immunoglobulin E (IgE)

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590701727
Basic UDI-DI: 150995901C22529QK
Reference: C22529
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

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: 06970150906603
Basic UDI-DI: 697015090000053H5
Reference: CMQ0602
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL IgE (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798364
Basic UDI-DI: B-06954414798364
Reference: /
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:33

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792164
Basic UDI-DI: B-06954414792164
Reference: /
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453482
Basic UDI-DI: 69506174IM440454DX
Reference: IM4403454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453475
Basic UDI-DI: 69506174IM440454DX
Reference: IM4407454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453468
Basic UDI-DI: 69506174IM440454DX
Reference: IM4402454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE (CLIA)

50 Tests; 100 Tests; 2×50 Tests; 2×100 Tests

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617453451
Basic UDI-DI: 69506174IM440454DX
Reference: IM4406454
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E (IgE) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334822950
Basic UDI-DI: B-06950334822950
Reference: 32027218
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:45

Manufacturer products Authorised representative products Authorised representative actors View details

Total Immunoglobulin E (Total IgE) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334815891
Basic UDI-DI: B-06950334815891
Reference: 52026210
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580453
Basic UDI-DI: 697518250P1150369
Reference: P11503
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin E CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293500123
Basic UDI-DI: 697518250F150092N
Reference: F15009
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:21

Manufacturer products Authorised representative products Authorised representative actors View details