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01.08.2026 16:25

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204 device results listed.

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Access Testosterone Reagent Pack

33560

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231347
Basic UDI-DI: 150995901AccTesto3L
Reference: 33560
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852272
Basic UDI-DI: B-06933289852272
Reference: WA67P0004
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852265
Basic UDI-DI: B-06933289852265
Reference: WA67P0003
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852258
Basic UDI-DI: B-06933289852258
Reference: WA67P0002
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289852241
Basic UDI-DI: B-06933289852241
Reference: WA67P0001
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 25.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (T) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762285
Basic UDI-DI: B-06971348762285
Reference: MF-18-25
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (T) Diagnostic Kit

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760304
Basic UDI-DI: B-06971348760304
Reference: MF-18-20
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-R14014ZN

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R14014ZN
Basic UDI-DI: B-R14014ZN
Reference: R14014
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R14013ZL

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R14013ZL
Basic UDI-DI: B-R14013ZL
Reference: R14013
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R14012ZJ

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R14012ZJ
Basic UDI-DI: B-R14012ZJ
Reference: R14012
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-R14011ZG

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R14011ZG
Basic UDI-DI: B-R14011ZG
Reference: R14011
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-6-62AG

Testosterone (Testo) Assay Kit (Chemiluminescent Microparticle Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-6-62AG
Basic UDI-DI: B-6-62AG
Reference: "REF: USIA00000095M, USIA00000096M"
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

+ENTIDNOV0090A

Free Testosterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV0090A
Basic UDI-DI: B-+ENTIDNOV0090A
Reference: DNOV009
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

+ENTIDNOV00203

Testosterone

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIDNOV00203
Basic UDI-DI: B-+ENTIDNOV00203
Reference: DNOV002
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:11

Manufacturer products View details

STANDARD™ i Testosterone

i-TET-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724077
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10D
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone (CLIA)

105-037228-00、105-037229-00

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157605
Basic UDI-DI: 69449040AB74000385V
Reference: 105-064656-00
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: 16.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone Test Kit (FIA)

VID56

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID563A
Basic UDI-DI: B-VID563A
Reference: VID56-05-011
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Aichek

TESTO Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-Testo706-AE5N
Basic UDI-DI: B-Testo706-AE5N
Reference: Testo706-AE10Y, Testo706-AE10N, Testo706-AE20Y, Testo706-AE20N
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-0845

Testosterone Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-0845
Basic UDI-DI: B-TD-HNKX-CED-0845
Reference: /
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Testosterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724084
Basic UDI-DI: 88001117IPBA01IA34W8
Reference: 16TES10F
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details