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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 01:15

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74 device results listed.

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STANDARD™ i SHBG

i-SHB-01

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726439
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10D
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i SHBG

-

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726446
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10F
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i SHBG

-

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111726453
Basic UDI-DI: 88001117IPBA01IA35WA
Reference: 16SHB10Q
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:05

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742956
Basic UDI-DI: B-06955792742956
Reference: S2152E-200
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742949
Basic UDI-DI: B-06955792742949
Reference: S2152E-150
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742932
Basic UDI-DI: B-06955792742932
Reference: S2152E-100
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742918
Basic UDI-DI: B-06955792742918
Reference: S2152E-50
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742901
Basic UDI-DI: B-06955792742901
Reference: S2152E-25
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone-binding Globulin Chemiluminescence Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792742925
Basic UDI-DI: B-06955792742925
Reference: S2152E-75
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:38

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Aormone-binding Globulin（SHBG）Assay Kit

100 Tests

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Leadman Biochemistry Co., Ltd.
Manufacturer SRN: CN-MF-000020150
UDI-DI: 06954376005531
Basic UDI-DI: B-06954376005531
Reference: 69543760F000716G
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

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

100Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518217
Basic UDI-DI: B-06925794518217
Reference: 3010697
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
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

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

50Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794518200
Basic UDI-DI: B-06925794518200
Reference: 3010677
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
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

AIA-PACK SHBG CONTROL SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213388
Basic UDI-DI: B-04560189213388
Reference: 0025438
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213371
Basic UDI-DI: B-04560189213371
Reference: 0025538
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

ST AIA-PACK SHBG CALIBRATOR SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213364
Basic UDI-DI: B-04560189213364
Reference: 0025338
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

++B261CANSHBG4010D9

96 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnostics Biochem Canada Inc.
Manufacturer SRN: CA-MF-000032449
UDI-DI: ++B261CANSHBG4010D9
Basic UDI-DI: B-++B261CANSHBG4010D9
Reference: CAN-SHBG-4010
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 01.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

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)

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