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EUDAMED Device Search

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05.07.2026 16:54

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Active filter:Manufacturer SRN:CN-MF-000014615

33 device results listed.

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Sample Reagent

U400077-20

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492243306
Basic UDI-DI: 697349224U4000770A000K5
Reference: U400077-20
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:41

Manufacturer products Authorised representative products Authorised representative actors View details

06973492242361

U400067-20

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242361
Basic UDI-DI: 697349224U4000670A000JL
Reference: U400067-20
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

Sample Reagent

U400070-20

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242354
Basic UDI-DI: 697349224U4000700A000GA
Reference: U400070-20
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

Sample Reagent

U400059-20

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242347
Basic UDI-DI: 697349224U4000590A000JV
Reference: U400059-20
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

06973492242330

U400064-20

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242330
Basic UDI-DI: 697349224U4000640A000HD
Reference: U400064-20
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

06973492242323

UP0204

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242323
Basic UDI-DI: 697349224U3000144A001F7
Reference: U300014-4
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

06973492242316

UP0202

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242316
Basic UDI-DI: 697349224U3000144A000F5
Reference: U300014-2
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

PortNAT Molecular Analyzer

PN0102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492242132
Basic UDI-DI: 697349224U3000103A000D6
Reference: U300010
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

06973492241708

U400014-100

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241708
Basic UDI-DI: 697349224U4000142A000FE
Reference: U400014-100
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

06973492241661

U400023-100

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241661
Basic UDI-DI: 697349224U4000232A000FJ
Reference: U400023-100
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

06973492241647

U400024-100

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241647
Basic UDI-DI: 697349224U4000242A000FX
Reference: U400024-100
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
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

06973492241630

UC0216

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241630
Basic UDI-DI: 697349224U3000064A000FE
Reference: U300006-16
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

06973492241623

UC0208

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241623
Basic UDI-DI: 697349224U3000054A000EZ
Reference: U300005-8
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

06973492240251

UC0116

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240251
Basic UDI-DI: 697349224U3000142A000EF
Reference: U30014
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

06973492241616

UC0204

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492241616
Basic UDI-DI: 697349224U3000044A000EL
Reference: U300004-4/U300005-8/U300006-16
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

MultNAT Molecular Diagnostic Testing System

UP0102/UP0104

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240619
Basic UDI-DI: 697349224U3000027A000ET
Reference: U300002-2
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

06973492240244

UC0108

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Ustar Biotechnologies (Hangzhou) Ltd.
Manufacturer SRN: CN-MF-000014615
UDI-DI: 06973492240244
Basic UDI-DI: 697349224U3000132A000E2
Reference: U30013
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

06973492240237

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

06973492240220

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

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