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366 device results listed.

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Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter II

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047988977
Basic UDI-DI: 0810047980013AGG
Reference: ACA403
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

ProciseDx Calibration Cartridge

4759

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

Manufacturer: ProciseDx Inc.
Manufacturer SRN: US-MF-000040747
UDI-DI: 08100322947594
Basic UDI-DI: 081003229PDXB475922V8
Reference: 4759
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

ProciseDx Analyzer

4390

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

Manufacturer: ProciseDx Inc.
Manufacturer SRN: US-MF-000040747
UDI-DI: 08100322943909
Basic UDI-DI: 081003229PDXA439022SS
Reference: 4390
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 03:33

Manufacturer products Authorised representative products Authorised representative actors View details

Veritor

BD Veritor™ InfoWiFi Module

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904450106
Basic UDI-DI: 038290KLOTORNEHM
Reference: 445010
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Veritor

BD Veritor™ Plus Analyzer

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

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382902560661
Basic UDI-DI: 038290ELAGYZIN7F
Reference: 256066
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

Curian Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733101427
Basic UDI-DI: 008407331CURIANCLA0016A
Reference: 610190
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

NIOX

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: NIOX AB
Manufacturer SRN: SE-MF-000010044
UDI-DI: 07350047030281
Basic UDI-DI: 735004703NIOXSENSORG2
Reference: 12-1650
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 21:08

Manufacturer products View details

ENNOLIFE Clinical Chemistry Analyzer (Non-sterile)

HCA-TE-300

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testing

Manufacturer: ProtectLife International Biomedical Inc.
Manufacturer SRN: TW-MF-000039217
UDI-DI: ++G322HCATE300
Basic UDI-DI: ++G322G322HCATE300MQQ8
Reference: HCA-TE-300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 15.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

QuickCheck

MBSQCR100

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: MicroBioSensor Ltd
Manufacturer SRN: GB-MF-000021594
UDI-DI: D-MBSQCR100MS
Basic UDI-DI: B-MBSQCR100MS
Reference: MBSQCR100
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

QuickCheck Cassette

MBSQCC100

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: MicroBioSensor Ltd
Manufacturer SRN: GB-MF-000021594
UDI-DI: D-MBSQCC100JH
Basic UDI-DI: B-MBSQCC100JH
Reference: MBSQCC100
EMDN: W0201069085
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: QNET B.V.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

On Call GU Dual Blood Glucose and Uric Acid Meter

OGM-201

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-GU114-11DK5
Basic UDI-DI: B-GU114-11DK5
Reference: GU114-11D
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230307

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230307
Basic UDI-DI: 697733823000DDJ
Reference: C61-LP100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047989073
Basic UDI-DI: 0810047980011AGA
Reference: ACA401r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cholesterol Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186848491
Basic UDI-DI: 0810047980011AGA
Reference: ACA401r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230116

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230116
Basic UDI-DI: 697733823000FDN
Reference: C61-GKUC100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047989004
Basic UDI-DI: 0810047980012AGD
Reference: ACA402r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter I

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186848507
Basic UDI-DI: 0810047980012AGD
Reference: ACA402r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose/Ketone/Uric Acid/Cholesterol Monitoring Meter II

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047988984
Basic UDI-DI: 0810047980013AGG
Reference: ACA403r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230666

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230666
Basic UDI-DI: 697733823000GDQ
Reference: C61-GKUC200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Uric Acid Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810186842895
Basic UDI-DI: 0810047980016AGR
Reference: ACA406r
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details