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06974613762041

AutraMicMini 3200

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613762041
Basic UDI-DI: 697461376020001T8
Reference: ZJYY-D-20215E
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

06974613760207

Autra4800 Plus

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613760207
Basic UDI-DI: 697461376010006T7
Reference: ZJYY-D-20222E
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974613760177

QGMate

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613760177
Basic UDI-DI: 697461376010005T5
Reference: ZJYY-D-20224E
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974613760191

AutraMic mini4800 Plus

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613760191
Basic UDI-DI: 697461376020003TC
Reference: ZJYY-D-20221E
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:00

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Automatic Sample Preprocessing Instrument

P12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041053
Basic UDI-DI: 6974591041005AY
Reference: P12
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:39

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561521301
Basic UDI-DI: 697456152NFast9600TG
Reference: NFast 9600
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 16:29

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Automatic Nucleic Acid Extraction System

CY-10, CY-11, CY-12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Huachenyang (Shenzhen) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000020236
UDI-DI: 06974488992055
Basic UDI-DI: 697448899CY-A1/3/8/2/8V73
Reference: CY-10
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

DNB Loader MGIDL-T7

MGIDL-T7

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130404
Basic UDI-DI: 697431813MGIDLKT
Reference: 900-000133-00
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic nucleic acid extractor

SMART-0596,SMART-4000,SMART-8000,SMART-4596Plus,SMART-4596Pro, SMART-8000Plus,SMART-4000Plus,Victoria_V96,Ava_V48,SMART-0548Mini

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Imadek Intelligent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000042852
UDI-DI: 06974312710565
Basic UDI-DI: 697431271001H2
Reference: SMART-0596
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

Magic-4000,Magic-8000,Magic-8000Plus,Magic-9000,Magic-8200,Magic-8200Plus,Magic-8400,Magic-8400Plus

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Imadek Intelligent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000042852
UDI-DI: 06974312710398
Basic UDI-DI: 697431271003H6
Reference: Magic-4000
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

Magic-2000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Imadek Intelligent Technology Co., Ltd.
Manufacturer SRN: CN-MF-000042852
UDI-DI: 06974312710367
Basic UDI-DI: 697431271005HA
Reference: Magic-2000
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 15:50

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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