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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

Dry immunoassay analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576207665
Basic UDI-DI: 697457620SSDiaXY
Reference: 1FF00003
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 11.08.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001162

FI-1200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001162
Basic UDI-DI: 692189300020052
Reference: 12000000300
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 11.08.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

06921893025427

NRM-FI-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893025427
Basic UDI-DI: 69218930001004V
Reference: 12000002900
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 23:24

Manufacturer products Authorised representative products Authorised representative actors View details

06921893001735

NRM411

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Norman Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000024233
UDI-DI: 06921893001735
Basic UDI-DI: 69218930057077C
Reference: 12000001100
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Bulgaria
Authorised representative: Sungo Cert GmbH
Last updated: 10.08.2026 07:03

Manufacturer products Authorised representative products Authorised representative actors View details

08809408862638

Surearly SMART App

IVD Class BIVDR 2017/746On the marketInstrumentSelf testing

Manufacturer: Sugentech, Inc.
Manufacturer SRN: KR-MF-000023952
UDI-DI: 08809408862638
Basic UDI-DI: 88094088SSMA-001A9
Reference: SSMA001E
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Spain
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 08.08.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

CubePlus

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

Manufacturer: opTricon GmbH
Manufacturer SRN: DE-MF-000024656
UDI-DI: 04252020400186
Basic UDI-DI: 42520204CPLUSAP
Reference: CUBE-941-03
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 22:54

Manufacturer products View details

LordsMed CLIA Reader

LM007

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Lord's Mark Industries Private Limited
Manufacturer SRN: IN-MF-000048403
UDI-DI: 08906194470068
Basic UDI-DI: 890619447LM007FB
Reference: LM007
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 07.08.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

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: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205777
Basic UDI-DI: 697457620FGWS01QT
Reference: GFQXY02Q
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

BIO-FLASH Narrow Tube Sample Adaptor

BIO-FLASH

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: 08436003070702
Basic UDI-DI: 84269506397259T
Reference: 3410-0872
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 05.08.2026 19:56

Manufacturer products View details