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01.08.2026 13:11

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23 device results listed.

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08033629921106

Beta Globin PlusTest

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629921106
Basic UDI-DI: B-08033629921106
Reference: AC104
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

08033629920994

Alfa Globin Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920994
Basic UDI-DI: B-08033629920994
Reference: AC099
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

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08033629920741

Beta Globin Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629920741
Basic UDI-DI: B-08033629920741
Reference: AC091
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

BT-Q Real Time PCR Kit (Beta Thalassemia)

G2M803321

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803321FC
Basic UDI-DI: B-G2M803321FC
Reference: G2M803321,G2M803321R
EMDN: W0106010111
EMDN description: THALASSAEMIA
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

Devyser Thalassemia

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631614
Basic UDI-DI: B-07350040631614
Reference: 8-A106-96
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser Thalassemia

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631607
Basic UDI-DI: B-07350040631607
Reference: 8-A106-48
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

Devyser Thalassemia

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040631591
Basic UDI-DI: B-07350040631591
Reference: 8-A106-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:13

Manufacturer products View details

EUYI β-Globin Gene Variation Test (PCR-RDB)

R24

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970934
Basic UDI-DI: B-06976457970934
Reference: 100THV-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

EUYI β-Globin Gene Variation Test

R24

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970057
Basic UDI-DI: B-06976457970057
Reference: 100THB-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

EUYI α-Thalassemia Genotyping Kit (Nondeletion)

R24

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970033
Basic UDI-DI: B-06976457970033
Reference: 100THS-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

EUYI α-Thalassemia Test (Gap-PCR)

R24

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970002
Basic UDI-DI: B-06976457970002
Reference: 100THA-24
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 00:47

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α/β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886115
Basic UDI-DI: B-06975358886115
Reference: 04110023
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α/β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886108
Basic UDI-DI: B-06975358886108
Reference: 04110022
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886016
Basic UDI-DI: B-06975358886016
Reference: 04110021
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE β-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358886009
Basic UDI-DI: B-06975358886009
Reference: 04110020
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885910
Basic UDI-DI: B-06975358885910
Reference: 04110019
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

PCR-CE α-Thalassemia Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Xiamen Biofast Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000027220
UDI-DI: 06975358885903
Basic UDI-DI: B-06975358885903
Reference: 04110018
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:29

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

8681957090072DY

FAST-HBB NGS Sequencing Kit

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

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090072DY
Basic UDI-DI: 8681957090072DY
Reference: M-HBB-01
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

Devyser Thalassemia v2

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

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040635209
Basic UDI-DI: 7350040638R117RJ
Reference: 8-R117-48
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details