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SALSA MLPA Probemix P095 Aneuploidy

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481321
Basic UDI-DI: 872021148P09569
Reference: P095-100R
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 07.08.2026 22:47

Manufacturer products View details

HLA B5701 Strip

3.155.XXX.YY.ZZZ

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002903
Basic UDI-DI: 84295773155WV
Reference: 3.155.016.53.000
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Spain
Safety summary (SSCP/SSP): DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative: -
Last updated: 07.08.2026 13:40

Manufacturer products Open in EUDAMED View details

HLA B5701 Strip

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002910
Basic UDI-DI: 84295773155WV
Reference: 3.155.048.53.000
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: -
Safety summary (SSCP/SSP): DO-040131 HLA B5701 Strip · Rev. 02
Authorised representative: -
Last updated: 07.08.2026 13:37

Manufacturer products Open in EUDAMED View details

560 Sizer Orange

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632079
Basic UDI-DI: 7350040638R402RL
Reference: 8-R402
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 06.08.2026 22:57

Manufacturer products View details

Devyser Index Plate LB-192

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632109
Basic UDI-DI: 7350040638R207RL
Reference: 8-R207
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 06.08.2026 22:57

Manufacturer products View details

Devyser Index Plate LB-A

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632048
Basic UDI-DI: 7350040638R202RA
Reference: 8-R202
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 06.08.2026 22:52

Manufacturer products View details

D-90060-RTDM

EliGene® Spondylitis HLA-B27 RT

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ELISABETH PHARMACON, spol. s r.o.
Manufacturer SRN: CZ-MF-000025244
UDI-DI: D-90060-RTDM
Basic UDI-DI: B-90060-RTDM
Reference: 90060-RT
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Czechia
Authorised representative: -
Last updated: 06.08.2026 18:39

Manufacturer products View details

NIPT-GeneSGKit CE-IVD 12 Reacciones

NIPT-GeneSGKit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SISTEMAS GENOMICOS. S.L.
Manufacturer SRN: ES-MF-000022949
UDI-DI: 08436566761215
Basic UDI-DI: 843656676121K8
Reference: LV3736
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 06.08.2026 07:08

Manufacturer products View details

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481093
Basic UDI-DI: 872021148P0825Y
Reference: P082-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 05.08.2026 23:04

Manufacturer products View details

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481109
Basic UDI-DI: 872021148P0825Y
Reference: P082-050R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

SALSA MLPA Probemix P082 NF1 mix 2

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481116
Basic UDI-DI: 872021148P0825Y
Reference: P082-100R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 05.08.2026 22:50

Manufacturer products View details

37350134361794

SPOT-it TREC, KREC & SMN1 Screening Kit

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

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361794
Basic UDI-DI: 7350134361799E
Reference: 4-2020-TKS
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 05.08.2026 16:34

Manufacturer products View details

37350134361183

SPOT-it TREC & KREC Screening Kit

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

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361183
Basic UDI-DI: 7350134361188S
Reference: 4-2015-TK
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 05.08.2026 16:34

Manufacturer products View details

Detection Kit for Human MTHFR Gene Polymorphism (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870781
Basic UDI-DI: B-06974081870781
Reference: MTHFR
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

HPA-FluoGene 1a/b Screen

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483830
Basic UDI-DI: B-04260152483830
Reference: 003 011 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

RBC-FluoGene ABO basic

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483779
Basic UDI-DI: B-04260152483779
Reference: 001 086 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483458
Basic UDI-DI: B-04260152483458
Reference: 003 015 048
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

HPA-FluoGene NX

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152483441
Basic UDI-DI: B-04260152483441
Reference: 003 015 010
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

RBC-Ready Gene ABO

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: inno-train Diagnostik GmbH
Manufacturer SRN: DE-MF-000024702
UDI-DI: 04260152480013
Basic UDI-DI: B-04260152480013
Reference: 001 010 012
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:14

Manufacturer products View details

SALSA MLPA Probemix P081 NF1 mix 1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211481062
Basic UDI-DI: 872021148P0815W
Reference: P081-025R
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 04.08.2026 22:57

Manufacturer products View details