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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

Sample Processing System

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033770
Basic UDI-DI: 69449040SHYQ-LA10******TX
Reference: CLIA SPL1000
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

CAL 8000、CAL 6000

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904048550
Basic UDI-DI: 69449040AB3000003ZF
Reference: CAL 8000
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

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

Automated Dosing System

AP-100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062220
Basic UDI-DI: 69449040AB41000012C
Reference: AP-100
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

EU 8600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053035729
Basic UDI-DI: 69449040AB310000523
Reference: EU 8600
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

CAL 9000, CAL 7000, CAL 7000E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053000345
Basic UDI-DI: 69449040AB3000025ZR
Reference: CAL 7000
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Liquid Handler

BK-ASP48，BK-ASP48P，BK-ASP96, etc.

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301356
Basic UDI-DI: 6936895BS01329
Reference: BK-ASP96
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Centrifuge

Class IMDR 2017/745On the marketActive device

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301226
Basic UDI-DI: 6936895BS0142B
Reference: BS014
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Sample Processing System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300175
Basic UDI-DI: 6936895BS00428
Reference: BS004
EMDN: W02069001
EMDN description: AUTOSAMPLERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

GENEDIAN

Nucleic Acid Extraction and Purification Kit

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244530051
Basic UDI-DI: 69342445RA004JS
Reference: P121-51048
EMDN: W02069085
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES
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

Nucleic Acid Extraction and Purification Kit (HPV)

IVD Class AIVDR 2017/746Not intended for EU marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: 06934244530044
Basic UDI-DI: 69342445RA003JQ
Reference: P121-52048
EMDN: W02069085
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES
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-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

Input Module, Model: iTLA Max In

iTLA Max

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734895
Basic UDI-DI: 692591270286HX
Reference: LX0255
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: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

06925912709077

iTLA mini Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912709077
Basic UDI-DI: 692591270312H7
Reference: IP0265
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: 31.07.2026 18:34

Manufacturer products Authorised representative products Authorised representative actors View details