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OGM-361

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497736
Basic UDI-DI: 6921756499990073XG
Reference: GN112-111-201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:10

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

06921026704403

Jet-iStar 800 Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Joinstar Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001083
UDI-DI: 06921026704403
Basic UDI-DI: 69210267JS800PDS
Reference: JS800P
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Primostar 3

Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200187
Basic UDI-DI: 6909262CNA003QD
Reference: 415501-0001-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Stemi 305

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200163
Basic UDI-DI: 6909262CNA001Q9
Reference: 435063-9010-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Axio Vert. A1

Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7

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

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200040
Basic UDI-DI: 6909262CNA002QB
Reference: 431030-9000-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra CDX System

CDX-10

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: 06438556100204
Basic UDI-DI: 6438556CDX-10RB
Reference: CDX-10-020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:55

Manufacturer products View details

Actim 1ngeni Instrument Check

19116IC

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

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: 06430030990844
Basic UDI-DI: 643003099ACTIM191165Y
Reference: 19116IC
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:51

Manufacturer products View details

Actim 1ngeni

19101AC

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

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: 06430030990837
Basic UDI-DI: 643003099ACTIM191015K
Reference: 19101AC
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 17:50

Manufacturer products View details

Cellbytes

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Cellbytes Ltd
Manufacturer SRN: FI-MF-000050442
UDI-DI: 06429830279808
Basic UDI-DI: 64298302798CBA8
Reference: CB
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:48

Manufacturer products View details

omnomicaNGS

omnomicsNGS

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Euformatics Oy
Manufacturer SRN: FI-MF-000030204
UDI-DI: 06429811494008
Basic UDI-DI: 6429811494oNGSHS
Reference: 06429811494008
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:47

Manufacturer products View details

Labmaster LUCIA™ Analyzer

LM26

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

Manufacturer: Labmaster Oy
Manufacturer SRN: FI-MF-000023942
UDI-DI: 06429810777003
Basic UDI-DI: 6429810777LM268N
Reference: LM26
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:45

Manufacturer products View details

06429810590077

Ocus M 20 MGU-30009

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590077
Basic UDI-DI: 6429810590MGU30009PB
Reference: MGU-30009
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

06429810590060

Ocus M 40 MGU-30008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590060
Basic UDI-DI: 6429810590MGU30008P9
Reference: MGU-30008
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

06429810590046

MGU-00005

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590046
Basic UDI-DI: 6429810590MGU00005N2
Reference: MGU-00005
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

06429810590022

Grundium Ocus40 MGU-00003

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590022
Basic UDI-DI: 6429810590MGU00003MW
Reference: MGU-00003
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

Grundium Ocus

MGU-00001

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590008
Basic UDI-DI: 6429810590MGU00001MS
Reference: MGU-00001
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

Manufacturer products View details

QC Cassette

IVD Class AIVDR 2017/746On the market

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587350004
Basic UDI-DI: 6419587QC0010PV
Reference: 740470
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

GP Reader NT

HIT-92A

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

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587343006
Basic UDI-DI: 6419587RNT0103T
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:36

Manufacturer products View details

Atellica DT 250 analyzer

Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság
Manufacturer SRN: HU-MF-000020416
UDI-DI: 05999883586747
Basic UDI-DI: 5999883586ADTVF
Reference: 11310504
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:47

Manufacturer products View details