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85 device results listed.

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MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32

MGX-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275996
Basic UDI-DI: 868459503MGX32QC
Reference: MGX-32
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:39

Manufacturer products View details

MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-16

MGX-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032350
Basic UDI-DI: 868459503MGX16QE
Reference: MGX-16
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:37

Manufacturer products View details

MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-2

MGX-2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032343
Basic UDI-DI: 868459503MGX2RM
Reference: MGX-2
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:37

Manufacturer products View details

06979117020024

G-MK02

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Geneus Technologies (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000050313
UDI-DI: 06979117020024
Basic UDI-DI: 697911702GS002ES
Reference: G-MK02
EMDN: W02050385
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06979117020017

G-seq500

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Geneus Technologies (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000050313
UDI-DI: 06979117020017
Basic UDI-DI: 697911702GS001EQ
Reference: G-seq500
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: 03.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR System

PCR Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780173
Basic UDI-DI: 697850778PCR10TL
Reference: IN0109
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

06978380060003

HTM-8T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Changhe Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000045901
UDI-DI: 06978380060003
Basic UDI-DI: 697838006CHMINIPCRYM
Reference: HTM-8T
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 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

06978022400013

Pure 32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Contin Instrument (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000045197
UDI-DI: 06978022400013
Basic UDI-DI: 69780224000137D
Reference: 06978022400013
EMDN: W02050392
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

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

06975614169044

NAT-3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genewise Bio Co., Ltd.
Manufacturer SRN: CN-MF-000038313
UDI-DI: 06975614169044
Basic UDI-DI: 697561416NAT1N7
Reference: NAT-3000
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

06975491760174

SEP-8、SEP-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760174
Basic UDI-DI: 697549176ADEAMIPM
Reference: SEP-8
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

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