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13 device results listed.

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Human BRCA1/2 Sequencing Panel Kit(Next Generation Sequencing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792733176
Basic UDI-DI: B-06955792733176
Reference: S3062E
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:59

Manufacturer products Authorised representative products Authorised representative actors View details

05745000468034

32 tests/kit, 64tests/kit

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468034
Basic UDI-DI: B-05745000468034
Reference: MFG030013, MFG030019
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

Manufacturer products View details

BRCA 1/2 Panel

G2MBR00001

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2MBR00001K8
Basic UDI-DI: B-G2MBR00001K8
Reference: G2MBR00001-ill,G2MBR00001-MG,G2MBR00001-TF
EMDN: W01060203
EMDN description: BRCA 1+2
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

D-9019BK

Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) Library Prep Kit for Illumina®

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: NimaGen BV
Manufacturer SRN: NL-MF-000022926
UDI-DI: D-9019BK
Basic UDI-DI: B-9019BK
Reference: RC-BRCA096-I
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:54

Manufacturer products View details

MULTIGEN

BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090034DQ
Basic UDI-DI: B-8681957090034DQ
Reference: M-BR-01
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Türkiye
Authorised representative: -
Last updated: 12.07.2026 15:41

Manufacturer products View details

BRCAaccuTest PLUS

NGB112V-024

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870106
Basic UDI-DI: B-08809539870106
Reference: NGB112V-024
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

BRCAaccuTest PLUS

NGB112V-012

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: NGeneBio Co., Ltd.
Manufacturer SRN: KR-MF-000042887
UDI-DI: 08809539870083
Basic UDI-DI: B-08809539870083
Reference: NGB112V-012
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 15:14

Manufacturer products Authorised representative products Authorised representative actors View details

Devyser BRCA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631775
Basic UDI-DI: B-07350040631775
Reference: 8-A100-24
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser BRCA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631270
Basic UDI-DI: B-07350040631270
Reference: 8-A100-96
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser BRCA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631263
Basic UDI-DI: B-07350040631263
Reference: 8-A100-8
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

GeneMind

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584039
Basic UDI-DI: B-06974968584039
Reference: L000178
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583162
Basic UDI-DI: B-06974968583162
Reference: L000043
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

06959094210519

24 tests/kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094210519
Basic UDI-DI: B-06959094210519
Reference: 8.06.0104
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Northern Ireland
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details