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810 device results listed.

Page 7 / 41

Leukemia Fusion Genes (Q55) Screening Kit

Leukemia Fusion Genes (Q55) Screening Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703686
Basic UDI-DI: B-06956299703686
Reference: 803540
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

CBFβ-MYH11 Detection Kit

CBFβ-MYH11 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703235
Basic UDI-DI: B-06956299703235
Reference: 803320
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

WT1 Detection Kit

WT1 Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703228
Basic UDI-DI: B-06956299703228
Reference: 803319
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 p210 Kit

BCR-ABL1 p210 Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703211
Basic UDI-DI: B-06956299703211
Reference: 803318
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 p190 Kit

BCR-ABL1 p190 Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703204
Basic UDI-DI: B-06956299703204
Reference: 803317
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

Leukemia Fusion Genes (Q51) Screening Kit

Leukemia Fusion Genes (Q51) Screening Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703198
Basic UDI-DI: B-06956299703198
Reference: 803100
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα Genotyping Kit

PML-RARα Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703075
Basic UDI-DI: B-06956299703075
Reference: 803216
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

BCR-ABL1 Genotyping Kit

BCR-ABL1 Genotyping Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703068
Basic UDI-DI: B-06956299703068
Reference: 803215
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα S Detection Kit

PML-RARα S Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703044
Basic UDI-DI: B-06956299703044
Reference: 803213
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα L Detection Kit

PML-RARα L Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703037
Basic UDI-DI: B-06956299703037
Reference: 803212
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

PML-RARα V Detection Kit

PML-RARα V Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703051
Basic UDI-DI: B-06956299703051
Reference: 803214
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:26

Manufacturer products Authorised representative products Authorised representative actors View details

AML1-ETO Detection Kit

AML1-ETO Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703020
Basic UDI-DI: B-06956299703020
Reference: 803209
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

Leukemia Fusion Genes (Q30) Screening Kit

Leukemia Fusion Genes (Q30) Screening Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703013
Basic UDI-DI: B-06956299703013
Reference: 803041
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)

DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303086
Basic UDI-DI: B-06955931303086
Reference: 213301
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)

DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303079
Basic UDI-DI: B-06955931303079
Reference: 213301
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

48T

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468836
Basic UDI-DI: B-05745000468836
Reference: MFG030014
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

OD002

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: OncoDNA
Manufacturer SRN: BE-MF-000021570
UDI-DI: 05430003021576
Basic UDI-DI: B-05430003021576
Reference: OD002
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:51

Manufacturer products View details

GenetiSure Dx Postnatal Assay

K1201A

IVD Class CIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571108697
Basic UDI-DI: 570057R0403P3011C040000N8
Reference: K1201A
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

Idylla™ EGFR Mutation Test

Idylla™ EGFR Mutation Test

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000843
Basic UDI-DI: 5415219A0270CC
Reference: A0270/6
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

TarCET Kit Metabolic Panel

TarCET Kit

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

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820198
Basic UDI-DI: 52980048MULTITN
Reference: ET201-00-2016
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details