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EUDAMED Device Search

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Active filter:Manufacturer SRN:CN-MF-000014615

33 device results listed.

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UC0104

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240237
Basic UDI-DI: 697349224U3000122A000DM
Reference: UC0104
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

UC0102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240220
Basic UDI-DI: 697349224U3000032A000DH
Reference: U30003
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT Rapid RSV Assay

EasyNAT Rapid RSV Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240206
Basic UDI-DI: 697349224U2020082B000G8
Reference: U20208
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT Rapid Flu Assay

EasyNAT Rapid Flu Assay

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240190
Basic UDI-DI: 697349224U2020062B000FE
Reference: U20206
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT UU Assay

EasyNAT UU Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240213
Basic UDI-DI: 697349224U2030032C000F5
Reference: U20303
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT GBS Assay

EasyNAT GBS Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240183
Basic UDI-DI: 697349224U2030112C000EU
Reference: U20311
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT BP Assay

EasyNAT BP Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240176
Basic UDI-DI: 697349224U2020092C000GU
Reference: U20209
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MP Assay

EasyNAT MP Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240169
Basic UDI-DI: 697349224U2020012C000DL
Reference: U20201
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT HSV 1&2 Assay

EasyNAT HSV 1&2 Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240152
Basic UDI-DI: 697349224U2030042C000FJ
Reference: U20304
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MG Assay

EasyNAT MG Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240145
Basic UDI-DI: 697349224U2030022C000EQ
Reference: U20302
EMDN: W0105010803
EMDN description: MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT MTC Assay

EasyNAT MTC Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240138
Basic UDI-DI: 697349224U2010032C000DP
Reference: U20103
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EasyNAT CT/NG Assay

EasyNAT CT/NG Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240121
Basic UDI-DI: 697349224U2030012C000EB
Reference: U203001-20
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

MultNAT Molecular Diagnostic Testing System

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240626
Basic UDI-DI: 697349224U3000027A000ET
Reference: U300002-4
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 16.06.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details