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EUDAMED Device Search

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22.09.2026 20:14

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847 device results listed.

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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

Manufacturer products View details

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 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

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

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

hCG IRMA KIT

IM2110

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216689
Basic UDI-DI: 150995905hCGIRMA3X
Reference: Im2110
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

Estrone RIA

Immunoassay DSL8700

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211615
Basic UDI-DI: 150995905DSL8700GE
Reference: DSL8700
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

Estrone Sulfate RIA

Immunoassay DSL5400

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211547
Basic UDI-DI: 150995905DSL5400FA
Reference: DSL5400
EMDN: W0102050204
EMDN description: ESTRONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

Inhibin A ELISA

Immunoassay DSL-10-28100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211417
Basic UDI-DI: 150995905InhibinAK9
Reference: DSL-10-28100T
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

AMH Gen II ELISA

Immunoassay A79765

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590206703
Basic UDI-DI: 150995905A79765VK
Reference: A79765
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

Access PAPP-A

A48571

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590204006
Basic UDI-DI: 150995903AccPAPPAJM
Reference: A48571
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

AFP screening IRMA KIT

Immunoassay A37404

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590203139
Basic UDI-DI: 150995905A37404SN
Reference: A37404
EMDN: W0102050299
EMDN description: PREGNANCY TESTING HORMONES - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

Access Unconjugated Estriol (Reagent Pack)

33570

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231187
Basic UDI-DI: 150995901AccuE3SE
Reference: 33570
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
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 Total βhCG (Reagent Pack)

A85264

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226213
Basic UDI-DI: 150995901AccTBhCGLW
Reference: A85264
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
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 Inhibin A (Reagent Pack)

A36097

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590203047
Basic UDI-DI: 150995901AccInhA82
Reference: A36097
EMDN: W0102050214
EMDN description: INHIBIN A/B (PRENATAL SCREENING)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-BHCG-302GG
Basic UDI-DI: B-FI-BHCG-302GG
Reference: FI-BHCG-302
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details