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Automated ECL Immunoassay Analyzer

eCL8000,eCL8000i,eCL8000p,eCL8000x, Robot_R1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062839
Basic UDI-DI: 6970341680120502H9
Reference: NA
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automated ECLImmunoassay Analyzer

eCL9000、eCL9600、eCL9900、eCL9900i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062365
Basic UDI-DI: 6970341680120503HB
Reference: 0120512
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Portable FIA Analyzer

VIM300H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210593
Basic UDI-DI: 697022176VIM300H00001MF
Reference: VIM300H-00-01
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Analyzer

VIM1000M6

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204172
Basic UDI-DI: 697022176VIM1000001D9
Reference: VIM1000M6-00-011
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Multifunction Meter VIM220H

VIM220H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204134
Basic UDI-DI: 697022176VIM220H001KM
Reference: VIM220H-00-011
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Analyzer VIM3000

VIM3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339200808
Basic UDI-DI: 697022176VIM300000011C7
Reference: VIM3000-00-011
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:11

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: 06936415977726
Basic UDI-DI: 69449040MYYQ-0104******89
Reference: MR-96T
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

06936415977634

CL-8000i、CL-8200i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977634
Basic UDI-DI: 69449040MYYQ-BM60*****FM
Reference: CL-8000i
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay 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: 06936415902612
Basic UDI-DI: 69449040MYYQ-BM6M******TG
Reference: CL-6000i
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

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Chemiluminescence Immunoassay Analyzer

CL-9000i/CL-9200i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977658
Basic UDI-DI: 69449040AB400000629
Reference: CL-9000i
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ AE-200

AE-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716402430
Basic UDI-DI: 69397164AE200LV
Reference: AE20-MA00-0002
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:23

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300698

ST-280p

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300698
Basic UDI-DI: 69372873AMTECHSTEN
Reference: ST-280p
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

06935740734004

IA-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740734004
Basic UDI-DI: 69357407IIA000001NM
Reference: /
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare

FS-1000

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

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289822817
Basic UDI-DI: 69332898CE2281FJ
Reference: W910
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 09:56

Manufacturer products Authorised representative products Authorised representative actors View details

On Call MultiPro Analyzer

OGM-221

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496337
Basic UDI-DI: 6921756499990003WT
Reference: G116-112-201
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex FIA Analyzer

iFIA-100

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756492285
Basic UDI-DI: 6921756499990021WV
Reference: F111-10211-201
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

NS Reader

5420100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172530010
Basic UDI-DI: 6438172532I0001RG
Reference: 5420100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS2400

5400200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172520011
Basic UDI-DI: 6438172520I0001Q5
Reference: 5400200
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

AutoDELFIA Automatic Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147335008
Basic UDI-DI: 6438147AutoDELFIA_PPP2
Reference: 1235-5110
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

GSP, Genetic Screening Processor

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147311040
Basic UDI-DI: 6438147GSP_7V
Reference: 2021-0010
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details