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GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFS22ARU

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907066
Basic UDI-DI: B-08809115907066
Reference: INFS22ARU
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
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

GluNEO plus Blood Glucose Monitoring System for self-testing

INFCH003K

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115906830
Basic UDI-DI: B-08809115906830
Reference: INFCH003K
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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 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

Gluco Check ExCEllent Blood Glucose Monitoring System for self-testing (mol)

INFS17BG

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115901569
Basic UDI-DI: B-08809115901569
Reference: INFS17BG
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFCL001A

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900890
Basic UDI-DI: B-08809115900890
Reference: INFCL001A
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFM001ACZ

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900876
Basic UDI-DI: B-08809115900876
Reference: INFM001ACZ
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

GluNEO Blood Glucose Monitoring System for self-testing

INFM001A

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900814
Basic UDI-DI: B-08809115900814
Reference: INFM001A
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 Monitoring System for self-testing

INFM21ACZ

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900739
Basic UDI-DI: B-08809115900739
Reference: INFM21ACZ
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

Gluco Check ExCEllent Blood Glucose Monitoring System for self-testing (mmol)

INFM17BG

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900562
Basic UDI-DI: B-08809115900562
Reference: INFM17BG
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Monitoring System for self-testing

INFM21A

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900500
Basic UDI-DI: B-08809115900500
Reference: INFM21AGR
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFM22A

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900395
Basic UDI-DI: B-08809115900395
Reference: INFM22A
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Monitoring System for self-testing

INFSS001L

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056164
Basic UDI-DI: B-08800323056164
Reference: INFSS001L
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFS22ANL

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056140
Basic UDI-DI: B-08800323056140
Reference: INFS22ANL
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System

M 400

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065113019
Basic UDI-DI: B-08800065113019
Reference: M400M10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 1070 Blood Glucose Monitoring System

G 300

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

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065110001
Basic UDI-DI: B-08800065110001
Reference: G300M10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 1Code Blood Glucose Monitoring System

G 400

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

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065106004
Basic UDI-DI: B-08800065106004
Reference: G400M10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

Novacheck Blood Glucose Meter (Glucometer)

Blood Glucose Meter (Glucometer)

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingSelf testingSingle use

Manufacturer: NOVATECH TIBBİ CİHAZ ÜRÜNLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000019017
UDI-DI: 08682328782008
Basic UDI-DI: B-08682328782008
Reference: LM-602
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Greece
Authorised representative: -
Last updated: 08.07.2026 19:22

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