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Fully automatic chemiluminescence immunoassay analyzer

AI-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576208587
Basic UDI-DI: 697457620SSFaciaMP
Reference: 2FF00001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 22.09.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

08809446480306

Q-Smart

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PROTIA Inc.
Manufacturer SRN: KR-MF-000026040
UDI-DI: 08809446480306
Basic UDI-DI: 880944648QSM29RD
Reference: MQSM2901
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

i-Track10

IS-810410

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696594
Basic UDI-DI: 5060169693968YX
Reference: TD 810400
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 22.09.2026 01:52

Manufacturer products Authorised representative products Authorised representative actors View details

i-Tracker10-C

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696587
Basic UDI-DI: 5060169693968YX
Reference: TD 810400-C
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 22.09.2026 01:52

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® SARS-2 control samples

IVD generalIVDDNo longer on the marketAnimal tissuesProfessional testingSingle use

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1204SCQQ
Basic UDI-DI: B-1204SCQQ
Reference: 1204SC
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 22.09.2026 00:37

Manufacturer products View details

mini VIDAS®

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026140441
Basic UDI-DI: B-03573026140441
Reference: 99737
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 23:27

Manufacturer products View details

VIDAS®

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026140427
Basic UDI-DI: B-03573026140427
Reference: 99735
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: France
Authorised representative: -
Last updated: 21.09.2026 23:26

Manufacturer products View details

Nutritional Assessment Kit

IVDD_27_MAR EB_A_Nutri_Ass_Kit

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414608990
Basic UDI-DI: B-00630414608990
Reference: 11539004
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:48

Manufacturer products View details

CSF Assessment Kit

IVDD_27_MAR EB_A_CFS_Ass_Kit

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414608914
Basic UDI-DI: B-00630414608914
Reference: 11539002
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:48

Manufacturer products View details

Kidney Assessment Kit

IVDD_27_MAR EB_A_Kidn_Ass_Kit

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414608785
Basic UDI-DI: B-00630414608785
Reference: 11539003
EMDN: W0201020282
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:48

Manufacturer products View details

Rapid-OR³ System check cartridge

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133013014
Basic UDI-DI: 880613305170CY
Reference: FPCC216
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid-OR³

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010648
Basic UDI-DI: 880613301064C4
Reference: FPRR040-11
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 21.09.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

00841007007643

Fluorescence Immunoassay Analyzer

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

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: 00841007007643
Basic UDI-DI: 84100700000O5Y
Reference: CTA-FAH
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

06973864380523

LiCA Smart

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864380523
Basic UDI-DI: 6973864380104EH
Reference: 04090113000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

06973864382923

LiCA PT 1000

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Chemclin Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000009729
UDI-DI: 06973864382923
Basic UDI-DI: 6973864380106EM
Reference: 04090115300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Czechia
Authorised representative: MedNet EC-REP GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoassay System AURYX 90

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514600304
Basic UDI-DI: 59075146AURYX90ZQ
Reference: I20-A0001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Poland
Authorised representative: -
Last updated: 21.09.2026 21:26

Manufacturer products View details

Getein 1150 Immunofluorescence Quantitative Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414795530
Basic UDI-DI: 695441479553KR
Reference: GP1006
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

CLIA-go Pro Chemiluminescence Immunoassay Analyzer

Lumini-C100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Healgen Life Science, LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 30850076346103
Basic UDI-DI: 0850076346Lumini-CET
Reference: GR-036
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.08.2026 06:00

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001728

NORMAN-CL211A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001728
Basic UDI-DI: 69218930057106Z
Reference: 12000003000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 11.08.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001711

NORMAN-CL211,NRM411-S7

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001711
Basic UDI-DI: 69218930057067A
Reference: 12000001500
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 11.08.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details