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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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02.08.2026 22:01

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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

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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

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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

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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

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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

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Immunoassay IM1381, IM3302

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214401
Basic UDI-DI: 150995905LHIRMAHQ
Reference: IM1381
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Progesterone

Immunoassay IM1188

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213817
Basic UDI-DI: 150995905IM11885T
Reference: IM1188
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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Immunoassay IM1138

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213701
Basic UDI-DI: 150995905IM11385C
Reference: IM1138
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Testosterone, direct

Immunoassay IM1119

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213657
Basic UDI-DI: 150995905IM111958
Reference: IM1119
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Testosterone

Immunoassay IM1087

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213626
Basic UDI-DI: 150995905IM10875L
Reference: IM1087
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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RIA Δ4-Androstenedione

Immunoassay, IM0674

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213015
Basic UDI-DI: 150995905IM067462
Reference: IM0674
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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ACTIVE® Dihydrotestosterone RIA

Immunoassay DSL9600I

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211653
Basic UDI-DI: 150995905DSL9600iRA
Reference: DSL9600i
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

ACTIVE® Androstanediol Glucuronide RIA

Immunoassay DSL9200

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211646
Basic UDI-DI: 150995905DSL9200FU
Reference: DSL9200
EMDN: W0102050112
EMDN description: ANDROSTANEDIOL-GLUCURONIDE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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Immunoassay DSL8900

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211622
Basic UDI-DI: 150995905DSL8900GQ
Reference: DSL8900
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

ACTIVE® Free Testosterone RIA

Immunoassay DSL4900

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211530
Basic UDI-DI: 150995905DSL4900FU
Reference: DSL4900
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

ACTIVE® Androstenedione RIA

Immunoassay, DSL3800

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211516
Basic UDI-DI: 150995905DSL3800FG
Reference: DSL3800
EMDN: W0102050101
EMDN description: ANDROSTENEDIONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

Ultra-Sensitive Estradiol RIA

Immunoassay DSL4800

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211523
Basic UDI-DI: 150995905DSL4800FP
Reference: DSL4800
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

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Immunoassay A21854

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590202132
Basic UDI-DI: 150995905E2RIA7Y
Reference: A21854, B89462
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

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Access Progesterone

33550

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231378
Basic UDI-DI: 150995901AccProgCW
Reference: 33550
EMDN: W0102050106
EMDN description: PROGESTERONE
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

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