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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

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

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

FORA COMFORT plus G30a

Blood Glucose Meter

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893239133
Basic UDI-DI: B-04719893239133
Reference: TD-4241
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

FORA Diamond GD50

Blood Glucose Monitoring System

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893239027
Basic UDI-DI: B-04719893239027
Reference: TD-4286
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

CLEVER CHECK TD-4125 Sistem pentru monitorizarea glicemiei

Blood Glucose Monitoring System

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893237757
Basic UDI-DI: B-04719893237757
Reference: TD-4125
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag 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: 04713945681734
Basic UDI-DI: B-04713945681734
Reference: 681.73
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag Self Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681727
Basic UDI-DI: B-04713945681727
Reference: 681.72
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag Self Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681710
Basic UDI-DI: B-04713945681710
Reference: 681.71
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag Self Monitoring Blood Glucose System

EM Tag

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681703
Basic UDI-DI: B-04713945681703
Reference: 681.70
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag 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: 04713945681697
Basic UDI-DI: B-04713945681697
Reference: 681.69
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Tag 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: 04713945681680
Basic UDI-DI: B-04713945681680
Reference: 681.68
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Neu Self Monitoring Blood Glucose System

EM2

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681598
Basic UDI-DI: B-04713945681598
Reference: 681.59
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Neu Self Monitoring Blood Glucose System

EM2

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681581
Basic UDI-DI: B-04713945681581
Reference: 681.58
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Neu Self Monitoring Blood Glucose System

EM2

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681574
Basic UDI-DI: B-04713945681574
Reference: 681.57
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Neu Self Monitoring Blood Glucose System

EM2

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681567
Basic UDI-DI: B-04713945681567
Reference: 681.56
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Neu Self Monitoring Blood Glucose System

EM2

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681536
Basic UDI-DI: B-04713945681536
Reference: 681.53
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Voice Self Monitoring Blood Glucose System

EMV 3.1

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesReagentSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681420
Basic UDI-DI: B-04713945681420
Reference: 681.42
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMax Voice Self Monitoring Blood Glucose System

EMV 3.1

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle useSterile

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681253
Basic UDI-DI: B-04713945681253
Reference: 681.25
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details