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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 PAPP-A KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632202
Basic UDI-DI: 426015763866BPAPP-AK0XXEX
Reference: 866075N
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S PlGF plus KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632196
Basic UDI-DI: 426015763859BPlGFpluKXXKY
Reference: 859075N
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S Inhibin A KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632165
Basic UDI-DI: 426015763850BInhibiAKXXL8
Reference: 850075N
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S sFlt-1 KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632158
Basic UDI-DI: 426015763845BsFlt-1K0XX36
Reference: 845075N
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

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B·R·A·H·M·S hCG+ß KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632134
Basic UDI-DI: 426015763841BhCG+bK00XXHM
Reference: 841050N
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

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

B·R·A·H·M·S Free ßhCG KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631892
Basic UDI-DI: 426015763809BFrebhCGKXXBA
Reference: 809075N
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

B·R·A·H·M·S uE3 KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631847
Basic UDI-DI: 426015763803BuE3K0000XX6E
Reference: 803075N
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

VIDAS® HCG

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064914
Basic UDI-DI: 357302BUDI000894UM
Reference: 30405
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

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

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

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

RIA Unconjugated Estriol

Immunoassay IM3594

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590219765
Basic UDI-DI: 150995905IM35946Q
Reference: IM3594
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:45

Manufacturer products View details

SHBG IRMA KIT

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

Free β-hCG IRMA KIT

IM2459

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217525
Basic UDI-DI: 150995905IM24596A
Reference: IM2459
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

hCG screening RIA KIT

Immunoassay IM2235

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217044
Basic UDI-DI: 150995905IM22355J
Reference: IM2235
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

FSH IRMA KIT

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