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976 device results listed.

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gb GENETIC FRUCTO

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925220
Basic UDI-DI: 85952239000004X2
Reference: 3252-050
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 01.08.2026 18:33

Manufacturer products View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173657006
Basic UDI-DI: B-00810173657006
Reference: N7001D
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656993
Basic UDI-DI: B-00810173656993
Reference: N7001C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

FetoGnost® Kit RHD

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Ingenetix GmbH
Manufacturer SRN: AT-MF-000001501
UDI-DI: 09120110505897
Basic UDI-DI: 912011050HUFGRXX8D
Reference: HUFG100
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Austria
Safety summary (SSCP/SSP): FB257_V04 · Rev. 3.0
Authorised representative: -
Last updated: 01.08.2026 00:39

Manufacturer products Open in EUDAMED View details

gb GENETIC A1AT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223925114
Basic UDI-DI: 85952239000001WU
Reference: 3251-025
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

gb GENETIC LACTO

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223921918
Basic UDI-DI: 85952239000007X8
Reference: 3219-025
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 31.07.2026 23:17

Manufacturer products View details

TarCET PGT

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820075
Basic UDI-DI: 52980048PGTZB
Reference: ET202-00-2016
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

VERACITY Advance

VERACITY NIPT Solution

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820013
Basic UDI-DI: 52980048NIPTTJ
Reference: EV101-00-2096
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

Yourgene® QST*R Base

Yourgene® QST*R

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680076
Basic UDI-DI: 506040268ANM3
Reference: AN0PLB2
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

Yourgene® Cystic Fibrosis Base

Yourgene® Cystic Fibrosis

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

Manufacturer: Yourgene Health UK Ltd
Manufacturer SRN: GB-MF-000024810
UDI-DI: 05060402680007
Basic UDI-DI: 506040268CFLR
Reference: CF2EUB2
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:43

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal 13 and 21 Enumeration Probe kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906044
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003
EMDN: W0106010304
EMDN description: PÄTAU SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

OzTGSO HLA MX11 Typing Kit

58010, 58011

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: TBG Biotechnology Corp.
Manufacturer SRN: TW-MF-000029664
UDI-DI: 04718050362028
Basic UDI-DI: 47180503600580107Z
Reference: 58010, 58011
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

04260224890658

HISTO TYPE Rainbow

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testing

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890658
Basic UDI-DI: 426022489HRTP01ACSC
Reference: 728220
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

04260224890580

FastQ® B*27 direct

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testing

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890580
Basic UDI-DI: 426022489FAQD01ACAS
Reference: 728201
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

XA AneuScore III

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813502
Basic UDI-DI: 42513158D-5613IVDLA
Reference: D-5613-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA AneuScore II

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813410
Basic UDI-DI: 42513158D-5609IVDM9
Reference: D-5609-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA X/Y

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813199
Basic UDI-DI: 42513158D-5608IVDM2
Reference: D-5608-100-OG
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA X/Y/18

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813182
Basic UDI-DI: 42513158D-5606IVDLL
Reference: D-5606-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA 13/18/21

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315811997
Basic UDI-DI: 42513158D-5607IVDLT
Reference: D-5607-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:57

Manufacturer products View details

XA AneuScore I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315811973
Basic UDI-DI: 42513158D-5604IVDL6
Reference: D-5604-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:57

Manufacturer products View details