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82 device results listed.

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MeltArray High Risk HPV Genotyping Assay (Sanity)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703808
Basic UDI-DI: B-06956299703808
Reference: 801946
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

MeltArray High Risk HPV Genotyping Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703792
Basic UDI-DI: B-06956299703792
Reference: 801943
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP22)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703716
Basic UDI-DI: B-06956299703716
Reference: 801949
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: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogen Panel (RPP40D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703693
Basic UDI-DI: B-06956299703693
Reference: 801917
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: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.1 System

Fully Automated Medical PCR Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703679
Basic UDI-DI: 695629970002NZ
Reference: 505103
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

Low Risk HPV Genotyping Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703495
Basic UDI-DI: B-06956299703495
Reference: 801916
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Italy
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP40)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703488
Basic UDI-DI: B-06956299703488
Reference: 801918
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: JOYSUN GROUP S.L.U
Last updated: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

FFPE DNA Extraction Kit (Model: Sanity 2.0)

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: 06956299703426
Basic UDI-DI: 695629970004P5
Reference: 608817
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

Sanity 2.0s System

Fully Automated Medical PCR Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703402
Basic UDI-DI: 695629970002NZ
Reference: 505102
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

Respiratory Pathogen Panel (RPP3D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703303
Basic UDI-DI: B-06956299703303
Reference: 801115
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity-2 Respiratory Pathogen Panel (RPP3)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703297
Basic UDI-DI: B-06956299703297
Reference: 801114
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703280
Basic UDI-DI: B-06956299703280
Reference: 801406
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703273
Basic UDI-DI: B-06956299703273
Reference: 801306
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703266
Basic UDI-DI: B-06956299703266
Reference: 801305
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299703259
Basic UDI-DI: B-06956299703259
Reference: 801304
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 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

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: 28.06.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details