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GLUCOLAB Auto-Coding Blood Glucose Test Strip

INFM22ANL

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115900593
Basic UDI-DI: B-08809115900593
Reference: INFM22ANL
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:56

Manufacturer products Authorised representative products Authorised representative actors View details

GCare Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663911
Basic UDI-DI: B-08806134663911
Reference: 0639C10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GCare Glucose

GBP-110

IVD Annex II List BIVDDOn the marketAnimal tissuesMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663713
Basic UDI-DI: B-08806134663713
Reference: GBP110S10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE PRIME Glucose Control Solution

IVD generalIVDDOn the marketNear-patient testingProfessional testing

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663515
Basic UDI-DI: B-08806134663515
Reference: 0635C10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE PRIME Blood Glucose Test Strip

GBP-100

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663416
Basic UDI-DI: B-08806134663416
Reference: GBP100S10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE LIPID TC Test Strip

GLC-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663218
Basic UDI-DI: B-08806134663218
Reference: GLC100S10
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE LIPID Profile Test Strip

GLP-100

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134663119
Basic UDI-DI: B-08806134663119
Reference: GLP100S10
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

respons®A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660750
Basic UDI-DI: B-08806134660750
Reference: 963207
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

PocketChem A1c Advanced Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660743
Basic UDI-DI: B-08806134660743
Reference: 107033
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

QDx A1c Advance Test kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660729
Basic UDI-DI: B-08806134660729
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134660712
Basic UDI-DI: B-08806134660712
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

INFS001L

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056171
Basic UDI-DI: B-08800323056171
Reference: INFS001L
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

Oh'Care Lite Blood Glucose Test Strip

INFS003A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056157
Basic UDI-DI: B-08800323056157
Reference: INFS003A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

1drop™ TBIL

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: 1drop Inc.
Manufacturer SRN: KR-MF-000026103
UDI-DI: 08800075500588
Basic UDI-DI: B-08800075500588
Reference: B20190
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-STAT™ HbA1c Test Kit

CS 4000

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065144402
Basic UDI-DI: B-08800065144402
Reference: CS400S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
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-STAT™ 2000 HbA1c Test Kit

CS 2000

IVD generalIVDDNo longer on the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065144105
Basic UDI-DI: B-08800065144105
Reference: CS200S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
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 Test Kit

MH 200

IVD generalIVDDNo longer on the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065142101
Basic UDI-DI: B-08800065142101
Reference: MH200S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
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™ 3 in 1 GHL Lactate Test Strip

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingReagentSelf testingSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065133123
Basic UDI-DI: B-08800065133123
Reference: M400S12
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
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™ Lactate Test Strip

L 400

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testingSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065133024
Basic UDI-DI: B-08800065133024
Reference: L400S10
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
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™ 1070 Blood Glucose Test Strip

G 300

IVD Annex II List BIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065130122
Basic UDI-DI: B-08800065130122
Reference: G300S10
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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