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GDH Glucose control solution

GDH

IVD self-testing devicesIVDDOn the marketReagentSelf testing

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421CSYDLT
Basic UDI-DI: B-471987421CSYDLT
Reference: N/A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

AP-10

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421AP-10STRIPE3SZ
Basic UDI-DI: B-471987421AP-10STRIPE3SZ
Reference: N/A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

AP-10

IVD self-testing devicesIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421AP-108W8C
Basic UDI-DI: B-471987421AP-108W8C
Reference: N/A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Star

GlucoSure Star Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699A08Q
Basic UDI-DI: B-47136487699A08Q
Reference: S70304, S70052, S70005, S70008
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Star

GlucoSure Star Blood Glucose Test Strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699ATAW
Basic UDI-DI: B-47136487699ATAW
Reference: S5636026, S5636046, S5636053, S5636084, S5636094
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus

Contrex Plus glucose control solution

IVD Annex II List BIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699ASAU
Basic UDI-DI: B-47136487699ASAU
Reference: S5800012
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Uric Acid Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AUT3C
Basic UDI-DI: B-47136487613AUT3C
Reference: S5640832 S5640833
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Uric Acid Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AUS3A
Basic UDI-DI: B-47136487613AUS3A
Reference: S5800343 S5800346
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Triglyceride Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ATT39
Basic UDI-DI: B-47136487613ATT39
Reference: S5640823 S5640821 S5640822 S5640824
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Triglyceride Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ATS37
Basic UDI-DI: B-47136487613ATS37
Reference: S5800342
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Blood Glucose Test Strip

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AT88
Basic UDI-DI: B-47136487613AT88
Reference: S5640432 S5640437 S5640439 S5640431
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Cholesterol Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ACTZK
Basic UDI-DI: B-47136487613ACTZK
Reference: S5640826 S5640829 S5640825 S5640827 S5640831 S5640828 S5640830
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Cholesterol Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ACSZH
Basic UDI-DI: B-47136487613ACSZH
Reference: S5800344 S5800345
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GCTU

MultiSure GCTU Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613A062
Basic UDI-DI: B-47136487613A062
Reference: S81001, S81002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AT83
Basic UDI-DI: B-47136487612AT83
Reference: S5640624, S5640451, S5640452
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AS7Z
Basic UDI-DI: B-47136487612AS7Z
Reference: S5800192
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK blood ketone test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AKT27
Basic UDI-DI: B-47136487612AKT27
Reference: S5640465, S5640466
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK ketone control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AKS25
Basic UDI-DI: B-47136487612AKS25
Reference: S5800269
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

THE EDGE

THE EDGE blood lactate test strips

IVD self-testing devicesIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487610ALTZR
Basic UDI-DI: B-47136487610ALTZR
Reference: S5638025
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

THE EDGE

THE EDGE lactate control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487610ALSZP
Basic UDI-DI: B-47136487610ALSZP
Reference: S5800024
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details