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82 device results listed.

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MTB Test Kit (Sanity 2.0)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702849
Basic UDI-DI: B-06956299702849
Reference: 801176
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

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: 06956299702832
Basic UDI-DI: B-06956299702832
Reference: 801307
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

Respiratory Pathogen Panel (RPP4D)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702788
Basic UDI-DI: B-06956299702788
Reference: 801113
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

Sanity-2 Respiratory Pathogen Panel (RPP4)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702771
Basic UDI-DI: B-06956299702771
Reference: 801112
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

Low Risk HPV Genotyping Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702740
Basic UDI-DI: B-06956299702740
Reference: 801013
EMDN: W0105041005
EMDN description: OTHER HPV - NA REAGENTS
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

High Risk HPV Genotyping Assay (MMCA)

High Risk HPV Cenotyping Assay (MMCA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702733
Basic UDI-DI: B-06956299702733
Reference: 801011
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

High 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: 06956299702726
Basic UDI-DI: B-06956299702726
Reference: 801170
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

MTB DNA Extraction Kit (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: 06956299702528
Basic UDI-DI: 695629970004P5
Reference: 608815
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Total RNA Blood Kit (Lab-Aid)

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: 06956299702399
Basic UDI-DI: 695629970004P5
Reference: 607107
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824s DNA Extraction Kit

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: 06956299702382
Basic UDI-DI: 695629970004P5
Reference: 607106
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824 MTB DNA Extraction Kit

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: 06956299702375
Basic UDI-DI: 695629970004P5
Reference: 607105
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid Virus RNA Extraction Kit

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: 06956299702368
Basic UDI-DI: 695629970004P5
Reference: 607104
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Total RNA Blood Kit (Lab-Aid 896)

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: 06956299702351
Basic UDI-DI: 695629970004P5
Reference: 610105
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

HPV DNA Extraction Kit (Lab-Aid 896)

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: 06956299702344
Basic UDI-DI: 695629970004P5
Reference: 610104
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

MTB DNA Extraction Kit (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: 06956299702313
Basic UDI-DI: 695629970004P5
Reference: 608115
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Sample Transfer Processing System

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

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702269
Basic UDI-DI: 695629970043PF
Reference: 506102
EMDN: A04010102
EMDN description: ASPIRATION AND TRANSFER FILTERS (>= 5 MICRONS)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.0-Pathogen Nucleic Acid Extraction Kit

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: 06956299702238
Basic UDI-DI: 695629970004P5
Reference: 608501
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva DNA Sample Collection Kit

IVD Sample Collection Kit

IVD Class AIVDR 2017/746On the marketDirect markingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702214
Basic UDI-DI: 695629970005P7
Reference: 401103
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.0 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: 06956299702108
Basic UDI-DI: 695629970002NZ
Reference: 505101
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824s Nucleic Acid Extraction System

Nucleic Acid Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702092
Basic UDI-DI: 695629970003P3
Reference: 501101
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 23:46

Manufacturer products Authorised representative products Authorised representative actors View details