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iFlash-Anti-TPO

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715313
Basic UDI-DI: 692591270009H3
Reference: C89004G-L
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-Tg

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711711
Basic UDI-DI: 692591270008GZ
Reference: C89003G-L
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

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

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416409
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02197C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

Theresa RUO Kit

Theresa RUO kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Navolab Diagnosztika Kft
Manufacturer SRN: HU-MF-000025337
UDI-DI: 05999862454005
Basic UDI-DI: 599986245415L
Reference: TK-0001
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:46

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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

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ASCA Screen IgA+IgG Dot for BDI

BlueDiverDot ASCA

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687338
Basic UDI-DI: 542502368BDDCROHNHE
Reference: AD ASCASDBD
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

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ASCA Screen IgA + IgG Dot

BlueDot ASCA

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687031
Basic UDI-DI: 542502368BDCROHN99
Reference: AD ASCASD
EMDN: W0102109018
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

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BlueDiver Quantrix Liver 10 IgG

BlueDiver Quantrix Liver

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023682067
Basic UDI-DI: 542502368BDQLIVERQV
Reference: LIVER10Q
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

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BlueDiver Quantrix ANA25 IgG

BlueDiver Quantrix

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023682005
Basic UDI-DI: 542502368BDQANA3C
Reference: ANA25Q-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Granular12 IgG

BlueDiver Dot

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681824
Basic UDI-DI: 542502368BDDGRANULARDB
Reference: GR12DIV-24
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot Synthetase10 IgG

BlueDiverDot Myositis

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681732
Basic UDI-DI: 542502368BDDMYOSITISTF
Reference: SYN10DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDiverDot Scleroderma10 IgG

BlueDiverDot Scleroderma

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681725
Basic UDI-DI: 542502368BDDSCLERODERMAKH
Reference: SCL10DIV-24
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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BlueDiverDot GAD IgG

BlueDiverDot GAD

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681664
Basic UDI-DI: 542502368BDDGADYB
Reference: GADIV-24 IgG
EMDN: W0102100299
EMDN description: NEURO-AUTO-IMMUNE DISEASE - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

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

Manufacturer products View details

BlueDiverDot Polymyositis/Scleroderma8 IgG

BlueDiverDot Polymyositis/Scleroderma

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681589
Basic UDI-DI: 542502368BDDPMSCLLT
Reference: PMS8DIV-24
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDiverDot Liver5 IgG

BlueDiverDot Liver

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681497
Basic UDI-DI: 542502368BDDLIVERKL
Reference: LISDIV-24
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details

BlueDiverDot Gastritis IgG

BlueDiverDot Gastritis

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

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681473
Basic UDI-DI: 542502368BDDGASTRITISC2
Reference: IFPCADIV-24
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:03

Manufacturer products View details