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Blood Glucose Meter

G-427B

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184630076
Basic UDI-DI: B-06939184630076
Reference: G-427B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Meter

G-425-3

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184627434
Basic UDI-DI: B-06939184627434
Reference: G-425-3
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 14:38

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Ino X Blood Glucose Meter

VGM49

IVD Annex II List BIVDDOn the marketInstrumentKitSelf testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211187
Basic UDI-DI: B-06937339211187
Reference: VGM49-69B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Bravo Blood Glucose Meter

VGM11

IVD Annex II List BIVDDOn the marketInstrumentKitSelf testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211170
Basic UDI-DI: B-06937339211170
Reference: VGM11-992
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Bravo Blood Glucose Monitoring System

VGM11

IVD Annex II List BIVDDOn the marketInstrumentKitSelf testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211163
Basic UDI-DI: B-06937339211163
Reference: VGM11-991
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Portugal
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

SLX-121

SLX-121 Lipid and Blood Glucose Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175039890
Basic UDI-DI: B-06934175039890
Reference: 3N001DD
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

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SLX-120

SLX-120 Lipid and Blood Glucose Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175039883
Basic UDI-DI: B-06934175039883
Reference: 3G001DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Portugal
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Smart

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037681
Basic UDI-DI: B-06934175037681
Reference: 2J003DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu2

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037421
Basic UDI-DI: B-06934175037421
Reference: 5D001DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037391
Basic UDI-DI: B-06934175037391
Reference: 1N002DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ UG

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026777
Basic UDI-DI: B-06934175026777
Reference: 1V001DD
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Voice

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175012480
Basic UDI-DI: B-06934175012480
Reference: 2K003DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Monitoring Meters

Poctor 800

IVD self-testing devicesIVDDOn the marketInstrumentMicrobial substancesProfessional testingSelf testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600269
Basic UDI-DI: B-06921807600269
Reference: JY06 poctor800
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

saneo® SV-GD 01 Blood Glucose Meter

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100918
Basic UDI-DI: B-06424180100918
Reference: SV-GD 01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

saneo® SV-GD 01 Self-Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100628
Basic UDI-DI: B-06424180100628
Reference: SV-GD 01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

GP Reader NT

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740454
Basic UDI-DI: B-06419587740454
Reference: 740450
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

Quick Test Reader

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587740409
Basic UDI-DI: B-06419587740409
Reference: 740400
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

GP Reader

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Biohit Oyj
Manufacturer SRN: FI-MF-000014642
UDI-DI: 06419587602332
Basic UDI-DI: B-06419587602332
Reference: 602330
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 03.08.2026 03:54

Manufacturer products View details

4SURE SMART

Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815559
Basic UDI-DI: B-05420040815559
Reference: GD86
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

i-ImmunDx™ Analyzer

S03A

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

Manufacturer: Seinda Biomedical Corporation
Manufacturer SRN: CN-MF-000047055
UDI-DI: 06972976460031
Basic UDI-DI: 697297646S03VG
Reference: S03A-004
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.08.2026 14:08

Manufacturer products Authorised representative products Authorised representative actors View details