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BLOTrix System 4/ BLOTrix Reader S1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270584
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrs1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:30

Manufacturer products View details

BLOTrix System 4/ BLOTrix Reader C1

BLOTrix System 4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioSciTec GmbH
Manufacturer SRN: DE-MF-000007888
UDI-DI: 04260497270553
Basic UDI-DI: 42604972700021MU
Reference: b4c4btrc1
EMDN: W0201069080
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 07.08.2026 19:28

Manufacturer products View details

Fully automatic chemiluminescence immunoassay analyzer

AI-120

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576208587
Basic UDI-DI: 697457620SSFaciaMP
Reference: 2FF00001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Washing Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576205777
Basic UDI-DI: 697457620FGWS01QT
Reference: GFQXY02Q
EMDN: W0201020185
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

1drop for Hospital

IVD generalIVDDOn the marketProfessional testing

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-DSW-A01PJS
Basic UDI-DI: B-DSW-A01PJS
Reference: 400
EMDN: W0201069082
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop for Hospital

1drop for i-Hospital

IVD generalIVDDOn the marketProfessional testing

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-DSW-I01PLJ
Basic UDI-DI: B-DSW-I01PLJ
Reference: 400
EMDN: W0201069082
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

1drop™ TBIL

1drop for T-BIL

IVD generalIVDDOn the marketProfessional testing

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: D-DSW-I02PLM
Basic UDI-DI: B-DSW-I02PLM
Reference: 05400
EMDN: W0201069082
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 06.08.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring System

VGM02

IVD Annex II List BIVDDOn the marketInstrumentKitSelf testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210906
Basic UDI-DI: B-06937339210906
Reference: VGM02-0Y1
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

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OGM-191

IVD Class CIVDR 2017/746On the marketInstrumentMicrobial substancesNear-patient testingProfessional testingSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497804
Basic UDI-DI: 6921756499990046XD
Reference: G115-13H-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0068A/B · Rev. 1.1
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:33

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-191

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756497774
Basic UDI-DI: 6921756499990045XB
Reference: G115-10H-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0068A/B · Rev. 1.1
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:33

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-151

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756471101
Basic UDI-DI: 6921756499990056XG
Reference: G113-151-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0001A/B · Rev. 1.2
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-541

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470982
Basic UDI-DI: 6921756499990053XA
Reference: G113-211-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0001A/B · Rev. 1.2
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-541

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470975
Basic UDI-DI: 6921756499990052X8
Reference: G113-111-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0001A/B · Rev. 1.2
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-212

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470494
Basic UDI-DI: 6921756499990044X9
Reference: G115-13W-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-212

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470463
Basic UDI-DI: 6921756499990043X7
Reference: G115-10W-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-211

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470364
Basic UDI-DI: 6921756499990040WZ
Reference: G115-13U-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

OGM-211

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470333
Basic UDI-DI: 6921756499990039XG
Reference: G115-10U-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470340
Basic UDI-DI: 6921756499990039XG
Reference: G115-11U-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470357
Basic UDI-DI: 6921756499990039XG
Reference: G115-12U-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

On Call

IVD Class CIVDR 2017/746On the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756470470
Basic UDI-DI: 6921756499990043X7
Reference: G115-11W-201
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: -
Safety summary (SSCP/SSP): SSP-0086A/B · Rev. 3.0
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.08.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details