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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

19.09.2026 23:37

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18 device results listed.

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D-06971808256880W7

CBFB/MYH11 gene fusion probe reagent

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Wuhan HealthCare Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000033113
UDI-DI: D-06971808256880W7
Basic UDI-DI: B-06971808256880W7
Reference: FP-028
EMDN: W01060211
EMDN description: INV (16)
First on market country: Czechia
Authorised representative: Kingsmead Service B.V.
Last updated: 06.08.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906341
Basic UDI-DI: 50558449LPH022J9
Reference: CE-LPH 022
EMDN: W01060211
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

geneMAP CBFB-MYH11 Inv(16) Detection Kit, 24T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405CBFRT24BJ
Basic UDI-DI: B-TRMF000028405CBFRT24BJ
Reference: CBF-RT24
EMDN: W01060211
EMDN description: INV (16)
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:20

Manufacturer products View details

SensiQuant CBFB/MYH11 Positive Control INV-16E

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370400
Basic UDI-DI: B-08057723370400
Reference: CTRL-046.E
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Positive Control INV-16D

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370394
Basic UDI-DI: B-08057723370394
Reference: CTRL-046.D
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Positive Control INV-16A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370387
Basic UDI-DI: B-08057723370387
Reference: CTRL-046.A
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Positive Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370370
Basic UDI-DI: B-08057723370370
Reference: CTRL-046
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Standard INV-16E

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370363
Basic UDI-DI: B-08057723370363
Reference: STD-046.E
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Standard INV-16D

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370356
Basic UDI-DI: B-08057723370356
Reference: STD-046.D
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Standard INV-16A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370349
Basic UDI-DI: B-08057723370349
Reference: STD-046.A
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant CBFB/MYH11 Standard

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370332
Basic UDI-DI: B-08057723370332
Reference: STD-046
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant Direct CBFB/MYH11 MasterMix INV-16E

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370325
Basic UDI-DI: B-08057723370325
Reference: SQTd-046.E
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant Direct CBFB/MYH11 MasterMix INV-16D

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370318
Basic UDI-DI: B-08057723370318
Reference: SQTd-046.D
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant Direct CBFB/MYH11 MasterMix INV-16A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370301
Basic UDI-DI: B-08057723370301
Reference: SQTd-046.A
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

SensiQuant Direct CBFB/MYH11 MasterMix

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOCLARMA S.R.L.
Manufacturer SRN: IT-MF-000030384
UDI-DI: 08057723370295
Basic UDI-DI: B-08057723370295
Reference: SQTd-046
EMDN: W01060211
EMDN description: INV (16)
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 21:36

Manufacturer products View details

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906358
Basic UDI-DI: 50558449LPH022J9
Reference: CE-LPH 022-S
EMDN: W01060211
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844923591
Basic UDI-DI: 50558449LPH022J9
Reference: CE-LPH 022
EMDN: W01060211
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

-

IVD Class CNot specifiedOn the market

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844923607
Basic UDI-DI: 50558449LPH022J9
Reference: CE-LPH 022-S
EMDN: W01060211
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 27.06.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details