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82 device results listed.

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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: 03.08.2026 23:25

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: 03.08.2026 23:25

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: 03.08.2026 23:25

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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: 31.07.2026 20:31

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: 31.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06956299702030
Basic UDI-DI: 695629970003P3
Reference: 501110
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: 31.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva RNA 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: 06956299701378
Basic UDI-DI: 695629970005P7
Reference: 401115
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:31

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Lab-Aid 824 HPV 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: 06956299700333
Basic UDI-DI: 695629970004P5
Reference: 604106
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: 31.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824 MTB DNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299700777
Basic UDI-DI: 695629970004P5
Reference: 604109
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824s Blood DNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299700814
Basic UDI-DI: 695629970004P5
Reference: 606101
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid Virus RNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299700968
Basic UDI-DI: 695629970004P5
Reference: 606104
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299700982
Basic UDI-DI: 695629970004P5
Reference: 602101
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 824s DNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701026
Basic UDI-DI: 695629970004P5
Reference: 606103
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Collection Kit

IVD Class ANot specifiedOn the marketDirect markingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701385
Basic UDI-DI: 695629970005P7
Reference: 401120
EMDN: W05019002
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Collection Kit

IVD Class ANot specifiedOn the marketDirect markingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701392
Basic UDI-DI: 695629970005P7
Reference: 401122
EMDN: W05019002
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Sanity 2.0-Pathogen Nucleic Acid Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701613
Basic UDI-DI: 695629970004P5
Reference: 608101
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Lab-Aid 960 Virus RNA Extraction Kit

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701637
Basic UDI-DI: 695629970004P5
Reference: 605104
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Collection Kit

IVD Class ANot specifiedOn the marketDirect markingSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701750
Basic UDI-DI: 695629970005P7
Reference: 401150
EMDN: W05019002
EMDN description: SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

MTB DNA Extraction Kit (Lab-Aid 960)

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701828
Basic UDI-DI: 695629970004P5
Reference: 605105
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Extraction Kit (Sanity 2.0)

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299701859
Basic UDI-DI: 695629970004P5
Reference: 608106
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: 02.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details