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384 device results listed.

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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

D-0166K

EasyMagPlex Autoimmune Diabetes Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-0166K
Basic UDI-DI: B-0166K
Reference: 340701HNE,340702HNE,340703HNE,340704HNE,340705HNE,340706HNE
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Insulin Control

Insulin Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021365
Basic UDI-DI: B-00816426021365
Reference: K73C-4M
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Insulin Calibrator

Insulin Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020412
Basic UDI-DI: B-00816426020412
Reference: KAI-072C
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Insulin

Insulin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020306
Basic UDI-DI: B-00816426020306
Reference: KAI-071
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors 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

Isletest™ ICA ELISA

7010

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070101
Basic UDI-DI: B-00083059070101
Reference: 7010
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
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

Isletest™ GAD ELISA

7009

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059070095
Basic UDI-DI: B-00083059070095
Reference: 7009
EMDN: W0102060105
EMDN description: GAD II ANTIBODIES AND OTHER ICA
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

HbA1c Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807165086QL
Basic UDI-DI: B-000012807165086QL
Reference: HWTS-OT091
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

08034049110767

Insulin ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110767
Basic UDI-DI: 8034049110767VS
Reference: DKO076
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

C-Peptide Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231458
Basic UDI-DI: 697846523HormoneB16J4
Reference: 2×100 test
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465231359
Basic UDI-DI: 697846523HormoneB17J6
Reference: 2×100 test
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ C-PEPTIDE

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405097
Basic UDI-DI: 697139043060284
Reference: 010602001
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ INSULIN

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405073
Basic UDI-DI: 697139043060182
Reference: 010601001
EMDN: W0102060103
EMDN description: INSULIN
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

INSULIN

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309171705
Basic UDI-DI: 5204309000083P8
Reference: 1418-1940
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

Access C-Peptide (Reagent Pack)

C33451

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590733377
Basic UDI-DI: 150995901AccCPep56
Reference: C33451
EMDN: W0102060101
EMDN description: C-PEPTIDE
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

C-Peptide CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577171009
Basic UDI-DI: 697015090000073HB
Reference: CMG0201
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin CLIA Microparticles

AutoLumo Analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577170965
Basic UDI-DI: 697015090000072H9
Reference: CMG0101
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

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

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06975182500058
Basic UDI-DI: 697518250P140015Z
Reference: P14001
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ C-PEPTIDE

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439883
Basic UDI-DI: 697139043060284
Reference: 010602101
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details