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756 device results listed.

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Automatic Chemistry Analyzer

CA2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522646960
Basic UDI-DI: 697052264YQ09KX
Reference: QD0401
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:46

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

LA 3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640043
Basic UDI-DI: 697052264YQ08KV
Reference: QD0301
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

LA 2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522640036
Basic UDI-DI: 697052264YQ03KK
Reference: QD0201
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: 30.06.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080758

Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080758
Basic UDI-DI: 697051408GICN2
Reference: GIC-H1W
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970514080734

Fully Automatic Kinetic Tube Reader

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080734
Basic UDI-DI: 697051408IGL200A5
Reference: IGL-200
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:07

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06970514080710

Full-Automatic Chemiluminescence Immunoassay System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genobio Pharmaceutical Co., Ltd.
Manufacturer SRN: CN-MF-000027997
UDI-DI: 06970514080710
Basic UDI-DI: 697051408FACISICZ
Reference: FACIS-I
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

06970341684785

eCL8000x

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

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341684785
Basic UDI-DI: 6970341680120501H7
Reference: 0120508
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Analyzer VIM2000

VIM2000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221762046
Basic UDI-DI: 697022176VIM2000001DS
Reference: VIM2000-00-011
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: 29.06.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

POCT Analyzer

VIM1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221762039
Basic UDI-DI: 697022176VIM100000011AR
Reference: VIM1000-00-011
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: 29.06.2026 23:34

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Fully Automatic IHC Staining System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06978497293356
Basic UDI-DI: 697180456CNT360HM
Reference: CNT360-M2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 29.06.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033794
Basic UDI-DI: 69449040AB4000002ZW
Reference: CL-2800i
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: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053089371
Basic UDI-DI: 69449040AB4000002ZW
Reference: CLIA 2600
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: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

ZENIT RA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ImmunoDiagnostic Systems France
Manufacturer SRN: FR-MF-000023843
UDI-DI: 03760173851034
Basic UDI-DI: 3760173851003YL
Reference: 42675
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:10

Manufacturer products View details

TGS TA

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ImmunoDiagnostic Systems France
Manufacturer SRN: FR-MF-000023843
UDI-DI: 03760173851058
Basic UDI-DI: 3760173851003YL
Reference: TGS00001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:10

Manufacturer products View details

06955792714779

Surelite 8

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792714779
Basic UDI-DI: 69557927Surelite0001XU
Reference: Surelite 16
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06955792714762

Surelite 8

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792714762
Basic UDI-DI: 69557927Surelite0001XU
Reference: Surelite 8
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06951045800299

SuperFlex

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800299
Basic UDI-DI: 69510458INST_SuperFlexR2G
Reference: SY36
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

SuperFlex

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800015
Basic UDI-DI: 69510458INST_SuperFlexXZ
Reference: SUPERFLEX-CE
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemiluminescence Immunoassay Analyzer

MT60, MT60S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821472
Basic UDI-DI: 69503348MTA001LH
Reference: MT60S
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemiluminescence Immunoassay Analyzer

MT60, MT60S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334821465
Basic UDI-DI: 69503348MTA001LH
Reference: MT60
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:44

Manufacturer products Authorised representative products Authorised representative actors View details