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476 device results listed.

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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

HOKAPI™ INSULIN

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06971390439876
Basic UDI-DI: 697139043060182
Reference: 010601101
EMDN: W0102060103
EMDN description: INSULIN
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

06970664751645

Glycosylated Hemoglobin Rapid Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC
Manufacturer SRN: CN-MF-000019125
UDI-DI: 06970664751645
Basic UDI-DI: B-06970664751645
Reference: 25Tests/Kit
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 07:33

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649572
Basic UDI-DI: B-06970522649572
Reference: CA1802
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide (C-P) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649190
Basic UDI-DI: B-06970522649190
Reference: CA1702A
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide(CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157728
Basic UDI-DI: 69449040004L-C-Peptide*NZ
Reference: 105-064664-00
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin(CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053158244
Basic UDI-DI: 69449040004L-Insulin***FX
Reference: 105-064661-00
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Insulin Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414743944
Basic UDI-DI: 695441479209K7
Reference: IF5146
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

C-Peptide Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414743913
Basic UDI-DI: 695441474391JL
Reference: IF5147
EMDN: W0102060101
EMDN description: C-PEPTIDE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details