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143 device results listed.

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Oh'Care Lite Blood Glucose Monitoring System for self-testing

INFS001LBG

IVD Annex II List BIVDDOn the marketInstrumentReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905949
Basic UDI-DI: B-08809115905949
Reference: INFS001LBG
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFS22A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905390
Basic UDI-DI: B-08809115905390
Reference: INFS22A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Blood Glucose Test Strip

INFSS17B

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905338
Basic UDI-DI: B-08809115905338
Reference: INFSS17B
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing

INFSS16B

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905291
Basic UDI-DI: B-08809115905291
Reference: INFSS16B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder STDI( CT/NG/UU) Multiplex Real-time PCR kit

IFMR-03

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905154
Basic UDI-DI: B-08809115905154
Reference: IFMR-03
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Plus Test Cartridge

IHM-0003

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904911
Basic UDI-DI: B-08809115904911
Reference: OHHS03ACZ
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

CLOVER A1c Self Test Cartridge

IGM-0023

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904881
Basic UDI-DI: B-08809115904881
Reference: INFHS02ASCZ
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Control Solution (Normal)

INFCH21APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904638
Basic UDI-DI: B-08809115904638
Reference: INFCN21APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

Gluco Check ExCEllent Blood Glucose Control Solution (High)

INFC17BCH

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904560
Basic UDI-DI: B-08809115904560
Reference: INFC17BCH
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Test Strip

INFS21ACZ

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904409
Basic UDI-DI: B-08809115904409
Reference: INFS21ACZ
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Test Strip

INFS21A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904393
Basic UDI-DI: B-08809115904393
Reference: INFS21A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Test Strip

INFS21APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904379
Basic UDI-DI: B-08809115904379
Reference: INFS21APT
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-ABCDRB1DQ RealAmp kit

IFMR-20

IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSterile

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904355
Basic UDI-DI: B-08809115904355
Reference: IFMR-20.02B006-CFX
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:58

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFinder HLA-B*57:01 RealAmp Kit

IFMR-22

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904324
Basic UDI-DI: B-08809115904324
Reference: IFMR-22.02B050
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Control solution (Normal&High)

INFS16BCZ

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904195
Basic UDI-DI: B-08809115904195
Reference: INFS16BCZ
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing

INFM16BICZ

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904188
Basic UDI-DI: B-08809115904188
Reference: INFM16BICZ
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

EASYGLUCO Auto-coding Blood Glucose Test Strip

INFS22ACZ

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904171
Basic UDI-DI: B-08809115904171
Reference: INFS22ACZ
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

EASYGLUCO Auto-coding Blood Glucose Monitoring System for self-testing

INFM22ACZ

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904164
Basic UDI-DI: B-08809115904164
Reference: INFM22ACZ
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Test Strip

INFS21A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904126
Basic UDI-DI: B-08809115904126
Reference: INFS21A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

Oh'Care Lite Blood Glucose Test Strip

INFS001LGR

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115903716
Basic UDI-DI: B-08809115903716
Reference: INFS001LGR
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details