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06974149860037

AutoRuby Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860037
Basic UDI-DI: 697414986AutoRubyDxQT
Reference: H693301
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:28

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

Singu32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870293
Basic UDI-DI: 697408187Singu324W
Reference: 029
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

Singu20

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870248
Basic UDI-DI: 697408187Singu204P
Reference: 043
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SysCan MedTech (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000039109
UDI-DI: 06973703911406
Basic UDI-DI: 697370391Model014GN
Reference: SSDM16-A
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150343

Rob 75

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150343
Basic UDI-DI: 697360915034KP
Reference: （01）6973609150343（11）210110（21）5382021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Sweden
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

06973609150329

SPS 1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150329
Basic UDI-DI: 697360915032KK
Reference: （01）6973609150329（11）210830（21）5B52021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Sweden
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

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06973609150114

ASP 150

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150114
Basic UDI-DI: 697360915011KB
Reference: （01）6973609150114（11）210830（21）5112021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - 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

Full Automatic Sample Handling System

EL-2600L,EL-2600M,EL-2600H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Huisong Technology Development Co., Ltd
Manufacturer SRN: CN-MF-000032903
UDI-DI: 06973368211224
Basic UDI-DI: 697336821EL001DC
Reference: 5003
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:32

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Extraction Workstation

SAW-96, SAW-48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342002541
Basic UDI-DI: 697334200SAW96GD
Reference: SAW-96
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction System

SSNP-2000B, SSSNP-3000A, SSNP-9600A,SMPE-960, SSNP-A6

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: 06973342000110
Basic UDI-DI: 697334200SSNPMP
Reference: SSNP-3000A
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740318

Speedry Incu

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740318
Basic UDI-DI: 697331674Incu001L3
Reference: A711011
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Full-automatic Nucleic Acids Extraction Instrument

VNP-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739726
Basic UDI-DI: 6973315739726BL
Reference: VNP-96
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acids Extraction Instrument

VNP-32YL

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739597
Basic UDI-DI: 6973315739597BZ
Reference: VNP-32YL
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Liquid Handling Workstation

VNL-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315738767
Basic UDI-DI: 6973315738675BM
Reference: VNL-96
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

06973049099127

AutoMimo R8

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049099127
Basic UDI-DI: 697304909Model701GJ
Reference: 11231
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Management Module

SDM

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Autobio Labtec Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000012110
UDI-DI: 06973049097499
Basic UDI-DI: 697304909Model027FZ
Reference: 07161
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 13:31

Manufacturer products Authorised representative products Authorised representative actors View details

XINKANG

φ13-16mm

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: JIANGSU XINKANG MEDICAL INSTRUMENT CO.LTD.
Manufacturer SRN: CN-MF-000010261
UDI-DI: 06972992549055
Basic UDI-DI: 697299254X006NY
Reference: φ13-16mm
EMDN: W02069002
EMDN description: TEST TUBE APPARATUSES
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

XINKANG

800

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: JIANGSU XINKANG MEDICAL INSTRUMENT CO.LTD.
Manufacturer SRN: CN-MF-000010261
UDI-DI: 06972992540038
Basic UDI-DI: 697299254X015NZ
Reference: 80-2
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 13:27

Manufacturer products Authorised representative products Authorised representative actors View details

Refrigerated microcentrifuge

91300

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: RWD Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000042234
UDI-DI: 06972860120096
Basic UDI-DI: 697286012913002Y
Reference: 91300
EMDN: W02069005
EMDN description: REFRIGERATED CENTRIFUGES
First on market country: Germany
Authorised representative: WISELINK MEDICAL, S.L.U.
Last updated: 02.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge

CT-G165R, CT-G185R, CT-Q175R, CT-D60, CL-G210R

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zhongke Meiling Cryogenics Company Limited.
Manufacturer SRN: CN-MF-000034599
UDI-DI: 06972244261179
Basic UDI-DI: 697224426LXJS6
Reference: /
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details