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EUDAMED Device Search

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

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iFlash-Testosterone

iFlash-Testosterone

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715436
Basic UDI-DI: 692591270017H2
Reference: C86031-L
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: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-FSH

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715368
Basic UDI-DI: 692591270012GQ
Reference: C86011-L
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-LH

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711797
Basic UDI-DI: 692591270011GN
Reference: C86010-L
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

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

IS-5700

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691353
Basic UDI-DI: 5060169691353X6
Reference: IS-5700
EMDN: W0102050108
EMDN description: PROLACTIN
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

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

IDS Androstenedione

IS-5400

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691261
Basic UDI-DI: 5060169691261WY
Reference: IS-5400
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
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

IDS-iSYS Free Testosterone

IDS-iSYS Free Testosterone

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169691230
Basic UDI-DI: 5060169691230WM
Reference: IS-5300
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
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

IDS-iSYS 17-OH Progesterone

IDS-iSYS 17-OH Progesterone

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690738
Basic UDI-DI: 5060169690738XP
Reference: IS-5100
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
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

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

Evidence MultiSTAT Testosterone

Evidence MultiSTAT Testosterone

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219555
Basic UDI-DI: 50552732BTESASS161RM
Reference: EV4513
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

B·R·A·H·M·S Prolactin KRYPTOR

B·R·A·H·M·S Prolactin KRYPTOR

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632028
Basic UDI-DI: 426015763824BProlactKXXBN
Reference: 824050N
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

VIDAS® Testosterone II

VIDAS® Testosterone II

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026415686
Basic UDI-DI: 357302BUDI000162T5
Reference: 414320
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:51

Manufacturer products View details

VIDAS® Prolactin

VIDAS® Prolactin

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064969
Basic UDI-DI: 357302BUDI000009SU
Reference: 30410
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® Progesterone

VIDAS® Progesterone

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064952
Basic UDI-DI: 357302BUDI000008SS
Reference: 30409
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® FSH

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064938
Basic UDI-DI: 357302BUDI000007SQ
Reference: 30407
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® LH

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064921
Basic UDI-DI: 357302BUDI000609TS
Reference: 30406
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

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

Immunoassay IM2125, IM3301

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216764
Basic UDI-DI: 150995905FSHIRMATA
Reference: IM2125
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

RIA 17α-Hydroxyprogesterone

Immunoassay, IM1452

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214715
Basic UDI-DI: 150995905IM14525M
Reference: IM1452
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details