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06974884776334

Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776334
Basic UDI-DI: 697488477TLH015Z2
Reference: TL59BRH
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884776198

Npex 96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776198
Basic UDI-DI: 697488477TLH019ZA
Reference: Y963H
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-E25

DNBSEQ-E25, DNBSEQ-E25A, DNBSEQ-T20×2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao MGI Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000022546
UDI-DI: 06974856880021
Basic UDI-DI: 697485688SEQ2U
Reference: 900-000850-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:37

Manufacturer products Authorised representative products Authorised representative actors View details

Easy Amp Real-time Fluorescence Isothermal Detection System

HWTS 1600P,HWTS 1600S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366389
Basic UDI-DI: 697484936W02050199W7
Reference: HWTS-EQ002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551068

ArchiPure 96 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551068
Basic UDI-DI: 6974795551006GY
Reference: ArchiPure 96 Pro
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

06974737220205

Automatic Nucleic Acid Detection and Analysis System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220205
Basic UDI-DI: 697473722AutoSAT47
Reference: AutoSAT
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

BNP027-5E

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 16974660730625
Basic UDI-DI: 697466073P02RZ
Reference: BNP027-5E 48pcs/box
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:10

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-N96

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

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730154
Basic UDI-DI: 697466073NAESN96P04G2
Reference: NAES-N96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-96Plus

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730147
Basic UDI-DI: 697466073NAES96PP04CC
Reference: NAES-96Plus
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-96

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730130
Basic UDI-DI: 697466073NAES96P04MJ
Reference: W
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-48

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730123
Basic UDI-DI: 697466073NAES48P04L9
Reference: NAES-48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-32

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730116
Basic UDI-DI: 697466073NAES32P04JL
Reference: NAES-32
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extracting System

AiNP 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212439
Basic UDI-DI: 697462121AiNPNW
Reference: AiNP 96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extracting System

AiNA32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212422
Basic UDI-DI: 697462121AiNAMY
Reference: AiNA32
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974613760160

QG28800

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613760160
Basic UDI-DI: 697461376020004TE
Reference: ZJYY-D-20220E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

06974591041145

H24

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041145
Basic UDI-DI: 6974591041006B2
Reference: H24
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

Uni-medica

NFAST 96, NFAST 32A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561520113
Basic UDI-DI: 697456152NFAST32ABE
Reference: 15.09.002.02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565035

AU1001,AU1001S,AU1001-96

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565035
Basic UDI-DI: 697454156003KX
Reference: AU1001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Croatia
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727308

CWX901/CWX902/CWX903

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727308
Basic UDI-DI: 697445472V21006X901-90344
Reference: CWX901
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction and Real-Time PCR System

ABT-24

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018025
Basic UDI-DI: 697432301YQ002FF
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 15:54

Manufacturer products Authorised representative products Authorised representative actors View details