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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

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

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

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

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

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

Microplate Reader

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 08887581001730
Basic UDI-DI: 69449040MYYQ-0104******89
Reference: MR-96A
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Hidex GammaDx

425-604

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hidex Oy
Manufacturer SRN: FI-MF-000056616
UDI-DI: 06429830313908
Basic UDI-DI: 64298303139AMGZP
Reference: 425-604
EMDN: W0201020203
EMDN description: GAMMA COUNTERS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Manufacturer products View details

GastroSoft

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740195
Basic UDI-DI: B-06419587740195
Reference: 740193
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

HYDROFLEX PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071160
Basic UDI-DI: 912005207IVS10080001AP4
Reference: 30190374
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

INFINITE F50 PLUS

Infinite F50 Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052071146
Basic UDI-DI: 912005207IVS10080000ANZ
Reference: 30183570
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

SW MAGELLAN V7.XSTD

Standard

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Tecan Austria GmbH
Manufacturer SRN: AT-MF-000020241
UDI-DI: 09120052070996
Basic UDI-DI: 912005207IVS10090000APE
Reference: 30183889
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:34

Manufacturer products View details

CUBE-S Analyser (700/546)

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

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: 09120044112024
Basic UDI-DI: 912004411CUBE3D
Reference: CA0110
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Austria
Authorised representative: -
Last updated: 01.08.2026 00:33

Manufacturer products View details

QDx Instacheck™-II

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010204
Basic UDI-DI: 880613301020BG
Reference: FPRR039
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598241783
Basic UDI-DI: 6970277510045Z23
Reference: AFR-602
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983192309
Basic UDI-DI: 6970277510044WZP
Reference: AFR-701
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details