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138 device results listed.

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iFlash-DGP IgA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912716761
Basic UDI-DI: 692591270116H5
Reference: C86073A
EMDN: W0102100699
EMDN description: CELIAC DISEASE - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-DGP IgG

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912716754
Basic UDI-DI: 692591270117H7
Reference: C86073G
EMDN: W0102100699
EMDN description: CELIAC DISEASE - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-tTG IgA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912716747
Basic UDI-DI: 692591270118H9
Reference: C86072A
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-tTG IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912716723
Basic UDI-DI: 692591270119HB
Reference: C86072G
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

anti-Gliadin sIgA ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598193116
Basic UDI-DI: B-04050598193116
Reference: K 9311
EMDN: W0102100604
EMDN description: GLIADIN ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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anti-human tissue transglutaminase sIgA (anti-htTG sIgA) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598193932
Basic UDI-DI: B-04050598193932
Reference: K 9393
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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anti-human epidermal transglutaminase IgA (anti-heTG IgA) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598193963
Basic UDI-DI: B-04050598193963
Reference: K 9396
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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anti-human tissue transglutaminase IgA (anti-htTG IgA) ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598193994
Basic UDI-DI: B-04050598193994
Reference: K 9399
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

BlueDiverDot Celiac IgA

BlueDiverDot Celiac

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681626
Basic UDI-DI: 542502368BDDCELIACR5
Reference: ENDADIV-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDot Celiac IgA

BlueDot Celiac

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680421
Basic UDI-DI: 542502368BDCELIACE4
Reference: ENDA-24
EMDN: W0102100602
EMDN description: TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

Celiac Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-OCEA-402AL
Basic UDI-DI: B-OCEA-402AL
Reference: OCEA-402
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76032GV7
Basic UDI-DI: B-DC76032GV7
Reference: DC76032G
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)

GGTTG-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GGTTG-402aOGJP
Basic UDI-DI: B-GGTTG-402aOGJP
Reference: GGTTG-402a
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Tissue-Transglutaminase IgA Rapid Test Cassette (Whole Blood)

GGTTG-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GGTTG-402aHGJ2
Basic UDI-DI: B-GGTTG-402aHGJ2
Reference: GGTTG-402a
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

MyTest Celiachia

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-300077LZ
Basic UDI-DI: B-300077LZ
Reference: 300077
EMDN: W0102100604
EMDN description: GLIADIN ANTIBODIES
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 25.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76488GP
Basic UDI-DI: B-DC76488GP
Reference: DC76488
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-tTG IgG

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76487GM
Basic UDI-DI: B-DC76487GM
Reference: DC76487
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-112F7

Anti-Endometrium IgM Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-112F7
Basic UDI-DI: B-6-112F7
Reference: "REF: USIA00000189M, USIA00000190M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-111F5

Anti-Endometrium IgG Assay Kit(Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-111F5
Basic UDI-DI: B-6-111F5
Reference: "REF: USIA00000191M, USIA00000192M"
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

AESKUSLIDES® EMA IgG

AESKUSLIDES® EMA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289503815
Basic UDI-DI: B-04250289503815
Reference: 512.101
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 15:44

Manufacturer products View details