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GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Full Set)

OG-PH05-HLM

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056188
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HL-2
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

XEVO TQ-S micro IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020179
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 186007833IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Waters 3777C Sample Manager IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020315
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 725000662IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

ACQUITY UPLC CM-A IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020117
Basic UDI-DI: 081677602MSTKPF0802BU
Reference: 186015043IVD
EMDN: W0201050201
EMDN description: HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-FLASH Waste Bottle

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070658
Basic UDI-DI: 84269506397259T
Reference: 3410-0827
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:39

Manufacturer products View details

Automated CLEIA system

DNK-MiniCL8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380187
Basic UDI-DI: 697529264012MV
Reference: E105
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

DNK-MiniCL16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380170
Basic UDI-DI: 697529264011MT
Reference: E106
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Automated CLEIA system

lumilite8s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Illumaxbio Technology Co.,LTD
Manufacturer SRN: CN-MF-000026407
UDI-DI: 06980222380033
Basic UDI-DI: 697529264003MU
Reference: E103
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

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: 06944904038049
Basic UDI-DI: 69449040SHYQ-BA2M******2F
Reference: BS-2000
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:14

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

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: 06944904018669
Basic UDI-DI: 69449040SHYQ-BA10******JV
Reference: BS-130
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:14

Manufacturer products Authorised representative products Authorised representative actors View details

Microplate Reader

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: 08887581001730
Basic UDI-DI: 69449040MYYQ-0104******89
Reference: MR-96A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

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: 06944904038032
Basic UDI-DI: 69449040SHYQ-BA2M******2F
Reference: BS-2200M
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

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: 06944904018652
Basic UDI-DI: 69449040SHYQ-BA10******JV
Reference: BS-120
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895302971
Basic UDI-DI: 6936895BS00326
Reference: BK-2000
EMDN: W0201010104
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h > 1.200)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 04.08.2026 22:05

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753654

URIT D 22 、UNAMAX D22

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753654
Basic UDI-DI: 69357407IUCS000004QS
Reference: USUC00000468
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753647

URIT D 21N、URIT D 22、UNAMAX D21

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753647
Basic UDI-DI: 69357407IUCS000003QQ
Reference: USUC00000467
EMDN: W020101020185
EMDN description: AUTOMATED URINE ANALYSERS - CONSUMABLES
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740753623

URIT-31、UC-32A、UC-32B、URIT-50、URIT-180、URIT-330、URIT-500、URIT-500C、URIT-560、UC-58、UC-280A、UC-280B、UC-600A、UC-50A、UC-50B、UC-50C、UNAMAX ONE、UNAMAX LITE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740753623
Basic UDI-DI: 69357407IUC000002WV
Reference: UYUC00000224
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935091676565

HT-1420A

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091676565
Basic UDI-DI: 69350916HT209MD
Reference: /
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 22:04

Manufacturer products Authorised representative products Authorised representative actors View details

06925912734857

iBC 900-A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734857
Basic UDI-DI: 692591270282HP
Reference: BC0244
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

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: 06903053035422
Basic UDI-DI: 69449040SHYQ-BA36******P9
Reference: Spin 360E
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details