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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

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

ImmuView® Reader 2.0

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: SSI Diagnostica A/S
Manufacturer SRN: DK-MF-000023933
UDI-DI: 05713106000076
Basic UDI-DI: 5713106ImmuView_Read23J8
Reference: 213414
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 12:12

Manufacturer products View details

i-Track 10 Trigger Set

IS-CT100

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420027
Basic UDI-DI: 5425030421024R9
Reference: TD IS-CT100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 System Liquid

IS-CS100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420010
Basic UDI-DI: 5425030421017RC
Reference: TD IS-CS100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

i-Track 10 Wash Solution

IS-CW100

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420003
Basic UDI-DI: 5425030421031R6
Reference: TD IS-CW100
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software

BlueScan/DrDot

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685013
Basic UDI-DI: 5425023685013VU
Reference: BLUESCAN1 + DR DOT LIC4
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

BlueDiver Instrument

Instrument

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023685006
Basic UDI-DI: 5425023685006VX
Reference: BLUEDIVER1
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

AIA-PACK WASH CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380033
Basic UDI-DI: 5430000495000020955MW
Reference: 0020955
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

AIA-PACK DILUENT CONCENTRATE

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Tosoh Europe N.V.
Manufacturer SRN: BE-MF-000000210
UDI-DI: 04562185380026
Basic UDI-DI: 5430000495000020956MY
Reference: 0020956
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:57

Manufacturer products View details

TruVue

TV100

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

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763396
Basic UDI-DI: 5065023763TV100VD
Reference: TV20001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 09:22

Manufacturer products Authorised representative products Authorised representative actors View details

B20

BB20-NH

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430053
Basic UDI-DI: 506096943BB20NHYQ
Reference: BB20-NH
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

B20

BB20-H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430046
Basic UDI-DI: 506096943BB20H2S
Reference: BB20-H
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BeeBlot

BB10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430039
Basic UDI-DI: 506096943BB1079
Reference: BB10
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BeeBlot

BB05

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430022
Basic UDI-DI: 506096943BB057G
Reference: BB05
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

RoboBlot

RB01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bee Robotics
Manufacturer SRN: GB-MF-000023998
UDI-DI: 05060969430008
Basic UDI-DI: 506096943RB01AQ
Reference: RB01
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CS Life Sciences Europe Ltd
Last updated: 31.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599402017
Basic UDI-DI: 5060599401038XK
Reference: RL-CLIA-1A
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

AGILITY

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Dynex Technologies Inc
Manufacturer SRN: US-MF-000014753
UDI-DI: 05060456180058
Basic UDI-DI: 506045618AGILITYBB
Reference: 67000
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 31.07.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details