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On Call MultiPro Analyzer

OGM-221

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756496337
Basic UDI-DI: 6921756499990003WT
Reference: G116-112-201
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

FIAflex FIA Analyzer

iFIA-100

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 26921756492285
Basic UDI-DI: 6921756499990021WV
Reference: F111-10211-201
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 09:25

Manufacturer products Authorised representative products Authorised representative actors View details

NS Reader

5420100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172530010
Basic UDI-DI: 6438172532I0001RG
Reference: 5420100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NS2400

5400200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172520011
Basic UDI-DI: 6438172520I0001Q5
Reference: 5400200
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

AutoDELFIA Automatic Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147335008
Basic UDI-DI: 6438147AutoDELFIA_PPP2
Reference: 1235-5110
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

GSP, Genetic Screening Processor

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147311040
Basic UDI-DI: 6438147GSP_7V
Reference: 2021-0010
EMDN: W0201020103
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

DELFIA Xpress

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147217328
Basic UDI-DI: 6438147DELFIA_XpressHQ
Reference: 6000-0010
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

Victor2 D

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147116126
Basic UDI-DI: 6438147Victor_DYK
Reference: 1420-020
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:03

Manufacturer products View details

QuikRead go Plus Instrument

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

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001683
Basic UDI-DI: 6438115QRgoPlusDR
Reference: 155378
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:02

Manufacturer products View details

QuikRead go Instrument

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

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115000167
Basic UDI-DI: 6438115QRgoInstrumentF8
Reference: 133893
EMDN: W0201020205
EMDN description: TURBIDIMETERS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:02

Manufacturer products View details

mariPOC® Quick Flu+ control samples

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370528
Basic UDI-DI: 6430080371224MCCF
Reference: 1224MC
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Filtration unit rack

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370481
Basic UDI-DI: 643008037A-44W9
Reference: A-44
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Test plate storage rack

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370474
Basic UDI-DI: 643008037A-43W7
Reference: A-43
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Bottletop dispenser stand

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370467
Basic UDI-DI: 643008037A-29WD
Reference: A-29
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Waste container

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370450
Basic UDI-DI: 643008037A-99G
Reference: A-9
EMDN: W0201020280
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370429
Basic UDI-DI: 643008037AD1-ST3
Reference: AD1-S
EMDN: W0201020292
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

mariPOC® Analyser

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370412
Basic UDI-DI: 643008037AD7-020HF
Reference: AD7-020
EMDN: W0201020299
EMDN description: LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details

RAMP 200

RAMP 200 (C2100 and C3100)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Response Biomedical Corp.
Manufacturer SRN: CA-MF-000034747
UDI-DI: 10627966005237
Basic UDI-DI: 627966RAMP200CR
Reference: C2100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Romania
Authorised representative: Emergo Europe B.V.
Last updated: 02.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic IHC Staining System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06978497293400
Basic UDI-DI: 697180456CNT360HM
Reference: CNT360E
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Chemiluminescence Immunoassay Analyzer

IVD Class ANot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802602744
Basic UDI-DI: 69268026ImmuF60001KS
Reference: Immu F6S
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details