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194 device results listed.

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ichroma™-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010266
Basic UDI-DI: 880613301026BU
Reference: FPRR022
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™-50 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010334
Basic UDI-DI: 880613301033BR
Reference: FPRR036
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

EZ POC Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010259
Basic UDI-DI: 880613301025BS
Reference: FPRR034
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010129
Basic UDI-DI: 880613301012BH
Reference: FPRR035
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010112
Basic UDI-DI: 880613301011BF
Reference: FPRR031
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-1

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010051
Basic UDI-DI: 880613301005BL
Reference: FPRR019
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-6

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010037
Basic UDI-DI: 880613301003BG
Reference: FPRR020
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Test Reader

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

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: 06978274250008
Basic UDI-DI: 6978274250000DG
Reference: aca-A01
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230017

Fluorescence Immunoassay Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230017
Basic UDI-DI: 697733823000ADC
Reference: F21-FR101
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

06977338230000

Rapid Test Reader

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230000
Basic UDI-DI: 697733823000HDS
Reference: L21-LR100
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

Lateral Flow (LF) Portable Reader Plus

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598239711
Basic UDI-DI: 6970277510019TZH
Reference: ATR-400 (Cup)
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Elisa Microplate Reader

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06978527670119
Basic UDI-DI: 6936895BS0052A
Reference: BK-EL10DA
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 10:43

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: 04252020400179
Basic UDI-DI: 42520204CPLUSAP
Reference: CUBE-840-02
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Finland
Authorised representative: -
Last updated: 16.07.2026 09:14

Manufacturer products View details

BeVigilant™ Reader

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

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00860000930987
Basic UDI-DI: 086000093099000011UM
Reference: 9000011
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

BeVigilant™ Reader

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

Manufacturer: Vigilant Biosciences, Inc.
Manufacturer SRN: US-MF-000013534
UDI-DI: 00860000930963
Basic UDI-DI: 086000093099000002UL
Reference: 9000002
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Vigilant Biosciences GmbH
Last updated: 16.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

00816870020068

IN013

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020068
Basic UDI-DI: 081687002IN013ZR
Reference: IN013
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

00816870020051

IN009

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020051
Basic UDI-DI: 081687002IN00925
Reference: IN009
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

00816870020013

IN008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020013
Basic UDI-DI: 081687002IN00823
Reference: IN008
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

00816870020006

IN010

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020006
Basic UDI-DI: 081687002IN010ZK
Reference: IN010
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
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

Rapid Cup Test Reader

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510327
Basic UDI-DI: 0810164510009NK
Reference: EQB01-RD
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details