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340 device results listed.

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06975358885118

96Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885118
Basic UDI-DI: B-06975358885118
Reference: 04110004
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

06975358885101

PCR-CE SMN1/2 Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885101
Basic UDI-DI: B-06975358885101
Reference: 04110003
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

06975358885019

96 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885019
Basic UDI-DI: B-06975358885019
Reference: 04110002
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

06975358885002

48 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885002
Basic UDI-DI: B-06975358885002
Reference: 04110001
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

144 tests/kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584022
Basic UDI-DI: B-06974968584022
Reference: L000154
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
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

GeneMind

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583841
Basic UDI-DI: B-06974968583841
Reference: L000111
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
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

GeneMind

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968583568
Basic UDI-DI: B-06974968583568
Reference: L000106
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
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

06974870710281

TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Ruiqi Gene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027697
UDI-DI: 06974870710281
Basic UDI-DI: B-06974870710281
Reference: BM150029
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974870710274

TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Ruiqi Gene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027697
UDI-DI: 06974870710274
Basic UDI-DI: B-06974870710274
Reference: BM150028
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 21:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974870710168

Human MTHFR (C677T) Gene Polymorphism Detection Kit (PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Ruiqi Gene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027697
UDI-DI: 06974870710168
Basic UDI-DI: B-06974870710168
Reference: P152H
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974870710151

Human MTHFR (C677T) Gene Polymorphism Detection Kit (PCR-Melting Curve Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Wuxi Ruiqi Gene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027697
UDI-DI: 06974870710151
Basic UDI-DI: B-06974870710151
Reference: P130H
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 21:00

Manufacturer products Authorised representative products Authorised representative actors View details

MELAS genetic mutation digital PCR detection kit

MS01-Y24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627343
Basic UDI-DI: B-06974689627343
Reference: 13309-2
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Spinal muscular atrophy (SMA) digital PCR detection kit

SM01-Y32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627091
Basic UDI-DI: B-06974689627091
Reference: 13203-2
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

MELAS genetic mutation digital PCR detection kit

MS01-Q24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626612
Basic UDI-DI: B-06974689626612
Reference: 13309-1
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details

Spinal muscular atrophy (SMA) digital PCR detection kit

SM01-Q32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626100
Basic UDI-DI: B-06974689626100
Reference: 13203-1
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892572
Basic UDI-DI: B-06974674892572
Reference: 18-01-0017
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing)

24 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892565
Basic UDI-DI: B-06974674892565
Reference: 18-01-0016
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012863

Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012863
Basic UDI-DI: B-06974323012863
Reference: ID017
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012856

Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012856
Basic UDI-DI: B-06974323012856
Reference: ID017
EMDN: W0106010116
EMDN description: OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:51

Manufacturer products Authorised representative products Authorised representative actors View details

06971532200203

30 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Guangzhou Hybribio Medicine Technology Ltd.
Manufacturer SRN: CN-MF-000027677
UDI-DI: 06971532200203
Basic UDI-DI: B-06971532200203
Reference: HBGA-THAL
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 12:59

Manufacturer products Authorised representative products Authorised representative actors View details