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GenePure Pro Nucleic Acid Purification System

NPA-32P, NPA-32E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220659
Basic UDI-DI: 697384322NPA002K2
Reference: NPA-32P
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

QuantGene 9600 Fluorescent Quantitative Detection System

FQD-96C(EA4), FQD-96C(EA5), FQD-96C(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220628
Basic UDI-DI: 697384322FQD005GY
Reference: FQD-96C(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure 96 Nucleic Acid Purification System

NPA-96, NPA-96T, NPA-96E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220598
Basic UDI-DI: 697384322NPA003K4
Reference: NPA-96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene K Plus Fluorescent Quantitative Detection System

FQD-48A(EA2), FQD-48A(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221243
Basic UDI-DI: 697384322FQD003GU
Reference: FQD-48A(EA2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene Mini Fluorescent Quantitative Detection System

FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221212
Basic UDI-DI: 697384322FQD001GQ
Reference: FQD-16A(EA2R)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene MiniS Fluorescent Quantitative Detection System

FQD-16B(EA2) , FQD-16B(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220710
Basic UDI-DI: 697384322FQD002GS
Reference: FQD-16B(EA2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor System

MultiEx 096

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Four E’s Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000023274
UDI-DI: 06973698770378
Basic UDI-DI: 697369877MultiEx096SQ
Reference: MultiEx 096
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor System

MultiEx 032

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Four E’s Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000023274
UDI-DI: 06973698770361
Basic UDI-DI: 697369877MultiEx032RW
Reference: MultiEx 032
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151135

ADC CH196

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151135
Basic UDI-DI: 697360915113KL
Reference: （01）6973609151135（11）210110（21）5B62021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151128

Nexor 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151128
Basic UDI-DI: 697360915112KJ
Reference: （01）6973609151128（11）200815（21）5B22020189
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609151111

Nexor 32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609151111
Basic UDI-DI: 697360915111KG
Reference: （01）6973609151111（11）210106（21）5B12021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Denmark
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150565

NA4424

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150565
Basic UDI-DI: 697360915056KZ
Reference: （01）6973609150565（11）210103（21）5562021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150183

Nexor 32M

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150183
Basic UDI-DI: 697360915018KR
Reference: （01）6973609150183（11）210105（21）5B92021001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Ireland
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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

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