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Sample processing instruments

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: CelltraZone Co., Ltd
Manufacturer SRN: KR-MF-000026492
UDI-DI: 08800038500341
Basic UDI-DI: 88000385CZEPREPSM
Reference: ALBCCZ002
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Javitech Consulting GmbH
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

HURO PATH® T

Sample processing instruments

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: CelltraZone Co., Ltd
Manufacturer SRN: KR-MF-000026492
UDI-DI: 08800038500327
Basic UDI-DI: 88000385CZHUROTVX
Reference: ALBCCZ003
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Javitech Consulting GmbH
Last updated: 31.07.2026 23:58

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

MQ60 proB

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403503
Basic UDI-DI: 697029753MRBU3
Reference: HGMQ60 proB
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

Please see IFU

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403466
Basic UDI-DI: 697029753HG2J
Reference: HGMQ60
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Sample Processing System

YN-PW9600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931304267
Basic UDI-DI: 695593130023101623JP
Reference: 2310PW
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Reagent Pipetting System

YN-MP9600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303123
Basic UDI-DI: 695593130023060001JV
Reference: 230601
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

YN-AP9610

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yaneng BIOscience (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000013666
UDI-DI: 06955931303116
Basic UDI-DI: 695593130023050001JJ
Reference: 230501
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Smear Instrument

SC-10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053140430
Basic UDI-DI: 69449040AB300002822
Reference: SC-10
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

EB-1000

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

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244500153
Basic UDI-DI: 69342445IA004FP
Reference: P111-00032
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

EB-1100

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

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244500146
Basic UDI-DI: 69342445IA003FM
Reference: P111-01032
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

Stream DP96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103080504
Basic UDI-DI: 69281030805XG2
Reference: DA8050
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Promotor NES-32 Nucleic Acid Extraction System

NES-32 Nucleic Acid Extraction System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756498115
Basic UDI-DI: 6921756499990013WW
Reference: P111-1011-201
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

05744003510139

BGI LMSP-192

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510139
Basic UDI-DI: 574400351EU0200070001RN
Reference: EU0200070001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

RP-10

Pretreatment System

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562432523
Basic UDI-DI: 4987562RP-104S
Reference: BL085582
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

Etzel I

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer SRN: DE-MF-000032559
UDI-DI: 04262400021047
Basic UDI-DI: 426240002EZMA
Reference: IVD2210104
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:30

Manufacturer products View details

ColorJet Nano

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Bio-Gram Diagnostics GmbH
Manufacturer SRN: DE-MF-000032559
UDI-DI: 04262400021030
Basic UDI-DI: 426240002CJN9K
Reference: IVD2203103
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:30

Manufacturer products View details

HELMED® Automated IFA Processor

20110009

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

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512565
Basic UDI-DI: 42502895HELMEDFH
Reference: REF.HEL-1000
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:57

Manufacturer products View details

HELIA® Automated Blot System

20110007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512558
Basic UDI-DI: 42502895HELIAG5
Reference: REF.LIA-1000
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:56

Manufacturer products View details

HELIOS® Automated IFA System

20110008

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512541
Basic UDI-DI: 42502895HELIOSGR
Reference: REF.IOS-1000
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:56

Manufacturer products View details

08809975891208

Auto-Pure 10B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891208
Basic UDI-DI: 88099758902007000488
Reference: Auto-Pure 10B
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details