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143 device results listed.

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GluNEO plus Blood Glucose Test Strip

INFM003KIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08056590231135
Basic UDI-DI: B-08056590231135
Reference: INFM003KIT
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

Oh'Care Lite Blood Glucose Control Solution (Low)

INFSS003AIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08033726180697
Basic UDI-DI: B-08033726180697
Reference: INFSS003AIT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

EXADEMIN® Fast Blood Glucose Monitoring System for self-testing

INFM003AIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08033726180680
Basic UDI-DI: B-08033726180680
Reference: INFM003AIT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

EXADEMIN® Fast Blood Glucose Test Strip

INFSS003AIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08033726180673
Basic UDI-DI: B-08033726180673
Reference: INFS003AIT
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

D48543

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180116
Basic UDI-DI: B-04260423180116
Reference: D48543
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (Low)

D48537

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180062
Basic UDI-DI: B-04260423180062
Reference: D48537
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

D48535

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180055
Basic UDI-DI: B-04260423180055
Reference: D48535
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (Normal)

D48539

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180048
Basic UDI-DI: B-04260423180048
Reference: D48539
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (High)

D48541

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180031
Basic UDI-DI: B-04260423180031
Reference: D48541
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Monitoring System for self-testing

D48531

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180024
Basic UDI-DI: B-04260423180024
Reference: D48531
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Control Solution (High)

21515

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110349
Basic UDI-DI: B-04260235110349
Reference: 21515
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Control Solution (Low)

21415

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110165
Basic UDI-DI: B-04260235110165
Reference: 21415
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Monitoring System for self-testing (mmol)

21514

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110332
Basic UDI-DI: B-04260235110332
Reference: 21514
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Test Strip

21467

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110325
Basic UDI-DI: B-04260235110325
Reference: 21467
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

21416

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110172
Basic UDI-DI: B-04260235110172
Reference: 21416
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Control Solution (Normal)

21414

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110158
Basic UDI-DI: B-04260235110158
Reference: 21414
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Monitoring System for self-testing (mg)

21499

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110141
Basic UDI-DI: B-04260235110141
Reference: 21499
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Monitoring System for self-testing

INFS003KG

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260072576513
Basic UDI-DI: B-04260072576513
Reference: INFS003KG
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Control Solution (High)

INFM003KG

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260072576506
Basic UDI-DI: B-04260072576506
Reference: INFM003KG
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details

HemoCue HbA1c 501 Analyzer

IGM-0026BM

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

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115902542
Basic UDI-DI: 880911590IGM0026BMUN
Reference: 405210
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:45

Manufacturer products Authorised representative products Authorised representative actors View details