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SCA-Q Real Time PCR Kit (Sickle Cell Anemia)

G2M803221

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803221F7
Basic UDI-DI: B-G2M803221F7
Reference: G2M803221,G2M803221R
EMDN: W0106010109
EMDN description: SICKLE CELL ANEMIA
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

YCM-Q Real Time PCR Kit (Y Chromosome Microdeletion)

G2M803021

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803021EV
Basic UDI-DI: B-G2M803021EV
Reference: G2M803021,G2M803021R
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

HLA B27-Q Real Time PCR Kit

G2M801121

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M801121EL
Basic UDI-DI: B-G2M801121EL
Reference: G2M801121, G2M801121R
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

Manufacturer products Authorised representative products Authorised representative actors View details

VERACITY & VERACITY HC IVD kit reagents and VEGA software

VERACITY IVD KIT REAGENTS for 48 samples

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: D-CY-MF-0000093819M
Basic UDI-DI: B-CY-MF-0000093819M
Reference: EV100-00-248
EMDN: W0106010301
EMDN description: DOWN'S SYNDROME
First on market country: Cyprus
Authorised representative: -
Last updated: 13.07.2026 13:39

Manufacturer products View details

Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Biorain biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000049232
UDI-DI: D-CNMF000049232R3300196W9
Basic UDI-DI: B-CNMF000049232R3300196W9
Reference: R33001-096
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Survival Motor Neuron(SMN)Gene Detection Kit (Digital PCR Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Biorain biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000049232
UDI-DI: D-CNMF000049232R3300148VW
Basic UDI-DI: B-CNMF000049232R3300148VW
Reference: R33001-048
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-9021B6

Partner and Localiser of BRCA2 (PALB2) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9021B6
Basic UDI-DI: B-9021B6
Reference: RC-PALB096-I
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9018BH

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9018BH
Basic UDI-DI: B-9018BH
Reference: RC-CFTR096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

D-9017BF

Cystic Fibrosis Transmembrane Conductance Regulator Gene (CFTR) Mutation Hotspots Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9017BF
Basic UDI-DI: B-9017BF
Reference: RC-CFHS096-I
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-90085-RTFE

EliGene® CELIAC DQ PLUS RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90085-RTFE
Basic UDI-DI: B-90085-RTFE
Reference: 90085-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

D-90071-RTE7

EliGene® Coeliac 3.0 RT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90071-RTE7
Basic UDI-DI: B-90071-RTE7
Reference: 90071-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

IntRaFast-Q SMA SCREENING KIT

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: SNP BİYOTEKNOLOJİ ARAŞTIRMA GELİŞTİRME VE ÜRETİM SANAYİ VE TİCARET LİMİTED ŞİRKETİLİMİTED
Manufacturer SRN: TR-MF-000036548
UDI-DI: D-86804222814035R
Basic UDI-DI: B-86804222814035R
Reference: 200R-40-01
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 12.07.2026 11:18

Manufacturer products View details

HLA B27 Strip

3.154.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773154WTGK
Basic UDI-DI: B-84295773154WTGK
Reference: 3.154.XXX.YY.ZZZ
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

CeliacStrip

3.152.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773152WPFZ
Basic UDI-DI: B-84295773152WPFZ
Reference: 3.152.XXX.YY.ZZZ
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

YChromStrip

3.151.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773151WMFN
Basic UDI-DI: B-84295773151WMFN
Reference: 3.151.XXX.YY.ZZZ
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

LactoStrip

3.135.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773135WPG2
Basic UDI-DI: B-84295773135WPG2
Reference: 3.135.XXX.YY.ZZZ
EMDN: W0106010402
EMDN description: LACTOSE INTOLERANCE (POLYMORPHISMS)
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

HemochromaStrip

3.130.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773130WDEH
Basic UDI-DI: B-84295773130WDEH
Reference: 3.130.XXX.YY.ZZZ
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

ThromboSrip

3.117.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773117WMFQ
Basic UDI-DI: B-84295773117WMFQ
Reference: 3.117.XXX.YY.ZZZ
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

FetoGnost® Kit RHD

IVD Class DNot specifiedOn the marketDirect markingKitProfessional testingReagent

Manufacturer: Ingenetix GmbH
Manufacturer SRN: AT-MF-000001501
UDI-DI: 09120110506405
Basic UDI-DI: 912011050HUFGRXX8D
Reference: HUFG500
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: -
Safety summary (SSCP/SSP): FB257_V04 · Rev. 3.0
Authorised representative: -
Last updated: 11.07.2026 15:57

Manufacturer products Open in EUDAMED View details

19358706000106

AlloSeq HCT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: CareDx Pty Ltd
Manufacturer SRN: AU-MF-000046711
UDI-DI: 19358706000106
Basic UDI-DI: B-19358706000106
Reference: ASHCT.1(96)-IVD
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details