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813 device results listed.

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ichroma™ System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133030172
Basic UDI-DI: 880613303017C9
Reference: FPCC152
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133006412
Basic UDI-DI: 880613300641CF
Reference: FPCC128
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Washing Cartridge

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133005392
Basic UDI-DI: 880613300594CX
Reference: SMFP-79
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M2 System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133001578
Basic UDI-DI: 880613300157C5
Reference: FPCC170
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACTION

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: DAS Srl
Manufacturer SRN: IT-MF-000035583
UDI-DI: 08059616660346
Basic UDI-DI: 805961666ACTIONJW
Reference: OR-9711510
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: Portugal
Authorised representative: -
Last updated: 16.07.2026 12:11

Manufacturer products View details

06977338230055

Automatic Chemiluminescence Immunoassay Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230055
Basic UDI-DI: 697733823000JDW
Reference: G21-CA101
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Chemiluminescence Analyzer

MT120S, MT120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334825043
Basic UDI-DI: 69503348MTA008LX
Reference: MT120S
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 10:47

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HM-JACKarcⅡ

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295657873
Basic UDI-DI: 4987295BU002ZT
Reference: 65787
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

GBC Chemiluminescence Analyzer (Non-Sterile)

GBC CLi120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: General Biologicals Corporation
Manufacturer SRN: TW-MF-000024694
UDI-DI: 04712803533789
Basic UDI-DI: 4712803534MGCLI120JP
Reference: 4MGCLI120
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details

SPINCHIP® SOFTWARE

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026646530
Basic UDI-DI: 357302BUDI002311TC
Reference: 425376
EMDN: W0201020182
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

SpinChip SampleTransfer

IVD Class AIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026646127
Basic UDI-DI: 357302BUDI002312TE
Reference: 543799
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:51

Manufacturer products View details

FIAPresto FIAVet

FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246207
Basic UDI-DI: 08600102462BBIITRI001AN
Reference: FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

NOVEOS® Immunoassay System Accessories

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879023046
Basic UDI-DI: 081687902NOVACCKX
Reference: 63165
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

NOVEOS® Immunoassay System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hycor Biomedical LLC
Manufacturer SRN: US-MF-000031449
UDI-DI: 00816879022995
Basic UDI-DI: 081687902NOVINST37
Reference: 63000
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

00816870024448

IN006-3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870024448
Basic UDI-DI: 081687002IN006-3UR
Reference: IN006-3
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020082

IN006-2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020082
Basic UDI-DI: 081687002IN006-2UP
Reference: IN006-2
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020075

IN006

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020075
Basic UDI-DI: 081687002IN006ZU
Reference: IN006
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic chemiluminescence Immunoassay Analyzer

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510341
Basic UDI-DI: 0810164510010N4
Reference: EQA01-CL
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer,Brand:Oupirou

Fluorescence Immunoassay Analyzer

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047985235
Basic UDI-DI: 0810047980010AG7
Reference: ACA001
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemiluminescence Immunoassay Analyzer,Brand:Asterlith

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983361
Basic UDI-DI: 0810047980003AGB
Reference: ACIR-ACO100
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details