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Last updated

21.09.2026 21:15

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23 device results listed.

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IRMA Anti-Insulin(e)

A36473, A36474

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: D-A36473UZ
Basic UDI-DI: B-A36473UZ
Reference: A36473, A36474
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Czechia
Authorised representative: -
Last updated: 21.09.2026 20:01

Manufacturer products View details

iStar-IAA

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76391G7
Basic UDI-DI: B-DC76391G7
Reference: DC76391
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-IAA

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76390G5
Basic UDI-DI: B-DC76390G5
Reference: DC76390
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-IAA

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76389GL
Basic UDI-DI: B-DC76389GL
Reference: DC76389
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-IAA

30 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76066FR
Basic UDI-DI: B-DC76066FR
Reference: DC76066
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Antibody Detection Kit (Chemiluminescence Immunoassay)

2×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224034
Basic UDI-DI: B-06942202224034
Reference: 3013848
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:50

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Antibody Detection Kit (Chemiluminescence Immunoassay)

1×100 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518453
Basic UDI-DI: B-06925794518453
Reference: 3010689
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Antibody Detection Kit (Chemiluminescence Immunoassay)

1×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518446
Basic UDI-DI: B-06925794518446
Reference: 3010669
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, IAA

IAA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404529
Basic UDI-DI: B-06924030404529
Reference: MY00337
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, IAA

IAA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403508
Basic UDI-DI: B-06924030403508
Reference: MY00235
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, IAA

IAA, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402990
Basic UDI-DI: B-06924030402990
Reference: MY00184
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-IAA

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718680
Basic UDI-DI: 692591270052H4
Reference: C89048G
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Isletest IAA ELISA

7011

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: BIOEUROPE GmbH
Manufacturer SRN: DE-MF-000039230
UDI-DI: D-7011AM
Basic UDI-DI: B-7011AM
Reference: 7011
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 04:28

Manufacturer products View details

iFlash-IAA

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723257
Basic UDI-DI: 692591270052H4
Reference: C89048G-S
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Insulin IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070769697
Basic UDI-DI: B-06975070769697
Reference: 18141001
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Insulin IgG (CLIA)

100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761868
Basic UDI-DI: B-06975070761868
Reference: 18141001
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human Insulin Autoantibodies (IAA) Detection Kit(CLIA)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674893333
Basic UDI-DI: B-06974674893333
Reference: 18-02-0205
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

03770024321012

AAI

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321012
Basic UDI-DI: B-03770024321012
Reference: AAI
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:30

Manufacturer products View details

Isletest™ IAA ELISA

7011

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070118
Basic UDI-DI: B-00083059070118
Reference: 7011
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL IAA (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414713497
Basic UDI-DI: B-06954414713497
Reference: /
EMDN: W0102060104
EMDN description: INSULIN ANTIBODY
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details