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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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Active filter:EMDN:W0102050110

232 device results listed.

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Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719600816
Basic UDI-DI: B-06972719600816
Reference: 215200007
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Hungary
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 15:33

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Test Kit (Dry Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Lansion Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000001086
UDI-DI: 06971763220360
Basic UDI-DI: B-06971763220360
Reference: 0036-03
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

FIA Go TES Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225936358
Basic UDI-DI: B-06971225936358
Reference: FIA47025
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (CLIA)

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048024
Basic UDI-DI: 69449040004H-TESTO*****HB
Reference: 105-004254-00
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Calibrators

-

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048352
Basic UDI-DI: 69449040004H-TESTO*****HB
Reference: 105-004294-00
EMDN: W0102050110
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Free Testosterone II. Gen. ELISA

Free Testosterone II. Gen. ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325033948
Basic UDI-DI: B-04049325033948
Reference: DM52181
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

5alpha-Dihydrotestosterone ELISA

5alpha-Dihydrotestosterone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030183
Basic UDI-DI: B-04049325030183
Reference: DB52021
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

Testosterone RIA (CT)

Testosterone RIA (CT)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325006805
Basic UDI-DI: B-04049325006805
Reference: MG12191
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:10

Manufacturer products View details

Testosterone ELISA

Testosterone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325001756
Basic UDI-DI: B-04049325001756
Reference: RE52151
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

TESTO-CT2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321531
Basic UDI-DI: B-03770024321531
Reference: TESTO-CT2
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:32

Manufacturer products View details

Free Testosterone ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110156
Basic UDI-DI: 8034049110156UP
Reference: DKO015
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

Testosterone ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110026
Basic UDI-DI: 8034049110026U9
Reference: DKO002
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

Testosterone Assay kit(Chemiluminescence Immunoassay Method）

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

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235272
Basic UDI-DI: 697846523HormoneB13HW
Reference: 2×100 test
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
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

Pylon Testosterone

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025422
Basic UDI-DI: 697648502TESTUJ
Reference: 10-2207 40 tests/kit
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ TESTOSTERONE

HOKAPI™ TESTOSTERONE

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

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716404953
Basic UDI-DI: 69713904304047W
Reference: 010404001
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
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

Free Testosterone ELISA

Free Testosterone ELISA

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

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030695
Basic UDI-DI: 4049325IVR06080015BTY
Reference: DB52181
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Testosterone Saliva Luminescence Immunoassay

Testosterone Saliva Luminescence Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030473
Basic UDI-DI: 4049325IVR06080007BTZ
Reference: 30191569
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Testosterone Saliva ELISA

Testosterone Saliva ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030121
Basic UDI-DI: 4049325IVR06080002BTJ
Reference: RE52631
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Testosterone Saliva Luminescence Immunoassay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030480
Basic UDI-DI: 4049325IVR06080007BTZ
Reference: 30191568
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: -
Authorised representative: -
Last updated: 30.06.2026 12:40

Manufacturer products View details

Testosterone (CLIA)

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053056465
Basic UDI-DI: 69449040AB74000385V
Reference: 105-037228-00
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details