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70 device results listed.

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NATBox System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: 06977537461755
Basic UDI-DI: 697753746CW07RE
Reference: CW07023Q
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

06977426530005

MultiEX 024L，MultiEX 016，MultiEX 096P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKit

Manufacturer: Guangzhou Four E’s Scientific Co., Ltd
Manufacturer SRN: CN-MF-000043042
UDI-DI: 06977426530005
Basic UDI-DI: 6977426530015D2
Reference: MultiEX 024L，MultiEX 016，MultiEX 096P
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490162

Deaou-ART04

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490162
Basic UDI-DI: 697605549002LT
Reference: Deaou-ART04
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490018

Deaou-RT96

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490018
Basic UDI-DI: 697605549001LR
Reference: N/A
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

CHK Biotech

Q9600 Q1600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Chuangkun Biotech Inc.
Manufacturer SRN: CN-MF-000032705
UDI-DI: 06976014643011
Basic UDI-DI: 697601464RFQPS012B
Reference: N/A
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

CHK Biotech

Q1602 Q1604 MQ96 MQ48

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Chuangkun Biotech Inc.
Manufacturer SRN: CN-MF-000032705
UDI-DI: 06976014642014
Basic UDI-DI: 697601464TFFQPS01EW
Reference: N/A
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

06975938851052

NE-02-K-12；NE-02-K-12M；NE-02-K-96；NE-02-H-96；NE-02-F-96；NE-12-T-24

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

Manufacturer: GUANGZHOU BAYBIO BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000030650
UDI-DI: 06975938851052
Basic UDI-DI: 697593885ANAISV9
Reference: NE-12-T-24
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

06975461700377

QuantReady K9600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lifereal Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000019191
UDI-DI: 06975461700377
Basic UDI-DI: 697546170QuantReadyKZ
Reference: QuantReady K9600
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:05

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Dock

PM001

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120066
Basic UDI-DI: 697532712PM001FP
Reference: PM001
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

06975196540088

RAA-F1620

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuxi Qitian Biological Science Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000023012
UDI-DI: 06975196540088
Basic UDI-DI: 697519654829QC
Reference: 829
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975196540057

RAA-F1628

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuxi Qitian Biological Science Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000023012
UDI-DI: 06975196540057
Basic UDI-DI: 697519654828QA
Reference: 828
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:24

Manufacturer products Authorised representative products Authorised representative actors View details

Automated PCR Analysis System

FlashDx® sSPRT™ 4T

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201050
Basic UDI-DI: 6974936202010408121UB
Reference: FlashDx® sSPRT™ 4T
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Detection System

FlashDx-1000-E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201036
Basic UDI-DI: 697493620FDX1000EVS
Reference: FlashDx-1000-E
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

06974884776204

iGenebox 3A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776204
Basic UDI-DI: 697488477TLH018Z8
Reference: Y062H
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Rapid Nucleic Acid Detector GenCase-S

GenCase-S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao MGI Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000022546
UDI-DI: 06974856880410
Basic UDI-DI: 697485688PRNAD3B
Reference: 900-000710-00
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
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

06974795551983

iFIND S2 、iFIND S4 、iFIND S8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551983
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S2
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
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

C10 easyPCR System

C10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626018
Basic UDI-DI: 697468962601S7
Reference: N/A
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974689625219

D20

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625219
Basic UDI-DI: 697468962521S8
Reference: NA
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

D30 Automatic Digital PCR System

D30

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625189
Basic UDI-DI: 697468962518SK
Reference: 30175
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

D50 Automatic Digital PCR System

D50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625172
Basic UDI-DI: 697468962517SH
Reference: 30171
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details