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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-STAT™ 2000 Analyzer

CS 2000

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065164004
Basic UDI-DI: B-08800065164004
Reference: CS200M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LabonaCheck™ A1c HbA1c Analyzer

MH 200

IVD generalIVDDNo longer on the marketInstrumentNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065162406
Basic UDI-DI: B-08800065162406
Reference: MH200M10
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ Hb Plus Hemoglobin Measuring System

H 400

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065152018
Basic UDI-DI: B-08800065152018
Reference: B400M10
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

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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Next PRO Glukomer

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: 08588008819036
Basic UDI-DI: B-08588008819036
Reference: TD-4125
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Slovakia
Authorised representative: MedNet EC-REP GmbH
Last updated: 08.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

lisubel®check LB-EMV3 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: 08470001866585
Basic UDI-DI: B-08470001866585
Reference: LB-EMV3
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 08.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

lisubel®check LB-EMV3 Blood Glucose Meter

EMV 3.1

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 08470001866509
Basic UDI-DI: B-08470001866509
Reference: LB-EMV3
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 08.07.2026 01:06

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Monitoring System for self-testing

INFSS003KIT

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08388766478366
Basic UDI-DI: B-08388766478366
Reference: INFSS003KIT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 07.07.2026 23:10

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

OGCare Kit (mmol/L) - HU

OGCare Blood Glucose Meter

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

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233963
Basic UDI-DI: B-08032937233963
Reference: 3880003HU
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Hungary
Authorised representative: -
Last updated: 07.07.2026 11:57

Manufacturer products View details

OGCare Kit - ENG

OGCare Blood Glucose Meter

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233925
Basic UDI-DI: B-08032937233925
Reference: 3880001E
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:57

Manufacturer products View details

Aria Blood Glucose Systems Kit - English

Aria Blood Glucose Meter

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

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233567
Basic UDI-DI: B-08032937233567
Reference: 3880005E
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:57

Manufacturer products View details

Aria Kit - Italiano

Aria Blood Glucose Meter

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

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233239
Basic UDI-DI: B-08032937233239
Reference: 3880005
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:57

Manufacturer products View details

Aria Kit

Aria Blood Glucose Meter

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

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233215
Basic UDI-DI: B-08032937233215
Reference: 3880005-10
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:56

Manufacturer products View details

Aria Glucometer

Aria Blood Glucose Meter

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

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937233208
Basic UDI-DI: B-08032937233208
Reference: 3880005G
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:56

Manufacturer products View details

OGCare Kit - GRK

OGCare Blood Glucose Meter

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingReagentSelf testing

Manufacturer: Biochemical Systems International S.p.A.
Manufacturer SRN: IT-MF-000028905
UDI-DI: 08032937232775
Basic UDI-DI: B-08032937232775
Reference: 3880001GR
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 11:56

Manufacturer products View details