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CM-320 Chemiluminescence Immunoassay Analyzer

CM-320

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520043
Basic UDI-DI: 69257945W0201020104D0KF
Reference: 3013359
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

CM-320i Chemiluminescence Immunoassay Analyzer

CM-320i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794520036
Basic UDI-DI: 69257945W0201020103D0KA
Reference: 3013370
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

CM-180 Chemiluminescence Immunoassay Analyzer

CM-180

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515025
Basic UDI-DI: 69257945W0201020102D0K5
Reference: 3015506
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963722959
Basic UDI-DI: 692196372293JG
Reference: BOSON 3000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 18:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer LEPU Quant 1600

LEPU Quant-Fluo 1600

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807605035
Basic UDI-DI: 692180760503F6
Reference: JY20LEPUQuant-Fluo1600
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800

LEPU Quant 800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentProfessional testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807601136
Basic UDI-DI: 692180760113EM
Reference: JY04LEPU Quant 800
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence immunochromatography analyzer LEPU Quant-Fluo800

LEPU Quant-Fluo800

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600726
Basic UDI-DI: 692180760072EY
Reference: JY05LEPU Quant-Fluo 800
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

06921026705264

Jet-iStar 800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Joinstar Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001083
UDI-DI: 06921026705264
Basic UDI-DI: 69210267JS800GJ
Reference: JS800
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Bulgaria
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

TestiQ

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio-Novum Sp. z o.o.
Manufacturer SRN: PL-MF-000048483
UDI-DI: 05905351316679
Basic UDI-DI: 5905351316BNA100UY
Reference: BNA-100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:02

Manufacturer products View details

Lysis reagent (HClO4 - 7%), 10 mL

Lysis reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280285
Basic UDI-DI: 5744003280LYSIS5N
Reference: RLA704
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

IL-3, 0,1 µg

IL-3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280292
Basic UDI-DI: 5744003280IL34Q
Reference: RLR004
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Stop reagent (HClO4), 100 mL

Stop reagent (HClO4)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280247
Basic UDI-DI: 574400328STOPFW
Reference: RLR011
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Stripping buffer, 100 mL

Stripping buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280261
Basic UDI-DI: 5744003280STRIP6M
Reference: RLA701
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Diluent (NaOH), 10 mL

Diluent (NaOH)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280223
Basic UDI-DI: 574400328DILUENTGG
Reference: RLR009
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

OPA Disc 25 mg, 20 pcs

OPA Discs

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280193
Basic UDI-DI: 574400328OPAHN
Reference: RLA708
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Wash buffer 200 mL

Wash buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280155
Basic UDI-DI: 574400328WASHDP
Reference: RLR007W.200
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Pipes buffer 100 mL

Pipes buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280124
Basic UDI-DI: 574400328PIPESBP
Reference: RLR006
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

05744003280117

Reagent kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280117
Basic UDI-DI: 574400328REAGK8U
Reference: RLA700
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Detergent for Histareader

Rinse solutions for Histareader

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280094
Basic UDI-DI: 574400328RINSECH
Reference: RLA705
EMDN: W0201020285
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details

Release 23SEP2013

ver 3.0-0612

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: RefLab Aps
Manufacturer SRN: DK-MF-000021844
UDI-DI: 05744003280049
Basic UDI-DI: 574400328SOFTWE5
Reference: v4.0-0613
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:38

Manufacturer products View details