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Last updated

21.09.2026 21:15

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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Automated Sample Processing System

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
LA-60 Sample Processing System

LA-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing
Manufacturer
DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN
CN-MF-000001891
UDI-DI
06925794519856
Basic UDI-DI
69257945W02060101D0YE
Reference
3016285
EMDN
W02060101
EMDN description
AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country
Austria
Authorised representative
SUNGO Europe B.V.
Last updated
31.07.2026 18:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
AILife Pajzsmirigy Extra OKOSLELET

AILife Pajzsmirigy Extra OKOSLELET

IVD Class AIVDR 2017/746On the market
Manufacturer
DiagnostIQ Korlátolt Felelősségű Társaság
Manufacturer SRN
HU-MF-000046944
UDI-DI
05999577910100
Basic UDI-DI
599957791SMRTHEXT001XN
Reference
5999577910100
EMDN
W02069092
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Hungary
Authorised representative
-
Last updated
31.07.2026 16:40
Manufacturer productsView details