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58 device results listed.

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SHBG (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063690
Basic UDI-DI: 69703416803205096K2
Reference: 0320509001
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG CLIA Microparticles

AutoLumo Analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543866
Basic UDI-DI: 697015090000033GX
Reference: CMF0803
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone Binding Globulin (CLIA)

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053063562
Basic UDI-DI: 69449040AB74000525P
Reference: 105-041714-00
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SHBG

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718062
Basic UDI-DI: 692591270163HE
Reference: C86054
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
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

Human Sex Hormone-binding Globulin Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit, 1×50 Tests/kit, 2×50 Tests/kit

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

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588685
Basic UDI-DI: 69257945W0102050109R0NV
Reference: 3013889
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

IDS SHBG

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691322
Basic UDI-DI: 5060169691322WT
Reference: IS-5600
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Evidence MultiSTAT SHBG

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219609
Basic UDI-DI: 50552732BSHBGAK163CA
Reference: EV4514
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

SHBG IRMA KIT

Immunoassay IM3532

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590219635
Basic UDI-DI: 150995905IM353262
Reference: IM3532
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

Access SHBG Reagent Pack

A48617

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590204037
Basic UDI-DI: 150995901AccSHBG2C
Reference: A48617
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

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iStar-SHBG

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76030F4
Basic UDI-DI: B-DC76030F4
Reference: DC76030
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
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

iStar-SHBG

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76332FP
Basic UDI-DI: B-DC76332FP
Reference: DC76332
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76331FM
Basic UDI-DI: B-DC76331FM
Reference: DC76331
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-SHBG

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76330FK
Basic UDI-DI: B-DC76330FK
Reference: DC76330
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:59

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Sex Hormone-Binding Globulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SHBG706-AE2D
Basic UDI-DI: B-SHBG706-AE2D
Reference: SHBG706-AE10Y, SHBG706-AE10N, SHBG706-AE20Y, SHBG706-AE20N
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-045PK

Sex hormone binding globulin (SHBG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-045PK
Basic UDI-DI: B-K90411-045PK
Reference: /
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

CrinoCheck SHBG

20 tests/ kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K42-SHBGYR
Basic UDI-DI: B-K42-SHBGYR
Reference: 811023/K42-SHBG
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKSHB-402aHG89
Basic UDI-DI: B-FKSHB-402aHG89
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKSHB-402a6K
Basic UDI-DI: B-FKSHB-402a6K
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-SHBG

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912721369
Basic UDI-DI: 692591270163HE
Reference: C86054-S
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
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

14562185400905

CL AIA-PACK SHBG ADJUSTER SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400905
Basic UDI-DI: B-14562185400905
Reference: 0029239
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details