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82 device results listed.

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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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

FFPE DNA Extraction Kit (Model: Lab-Aid 824s)

Nucleic Acid Extraction Kit

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

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703099
Basic UDI-DI: 695629970004P5
Reference: 606904
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: Poland
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: Poland
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: Poland
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702979
Basic UDI-DI: B-06956299702979
Reference: 801219
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/PZA Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702962
Basic UDI-DI: B-06956299702962
Reference: 801218
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/STR Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702955
Basic UDI-DI: B-06956299702955
Reference: 801217
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/EMB Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702948
Basic UDI-DI: B-06956299702948
Reference: 801216
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MDR-TB Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702917
Basic UDI-DI: B-06956299702917
Reference: 801213
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacteria Identification Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702900
Basic UDI-DI: B-06956299702900
Reference: 801210
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/SL Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702894
Basic UDI-DI: B-06956299702894
Reference: 801206
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/FQ Test Kit (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702887
Basic UDI-DI: B-06956299702887
Reference: 801205
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MTB/MDR Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702870
Basic UDI-DI: B-06956299702870
Reference: 801181
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacteria Identification Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702863
Basic UDI-DI: B-06956299702863
Reference: 801180
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MDR-TB Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702856
Basic UDI-DI: B-06956299702856
Reference: 801177
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details