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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

THE EDGE

THE EDGE Blood Lactate Monitoring System

IVD self-testing devicesIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487610A05K
Basic UDI-DI: B-47136487610A05K
Reference: S54108, S54153, S54154, S54155, S54156, S54157, S54158
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

KETOSURE POC

KETOSURE POC Blood Ketone Test Strips

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BKT3J
Basic UDI-DI: B-47136487609BKT3J
Reference: S5640894
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC Ketone Control Solution

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BKS3G
Basic UDI-DI: B-47136487609BKS3G
Reference: S5800358
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KET-1

KET-1 Blood Ketone Monitoring System

IVD self-testing devicesIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609A06R
Basic UDI-DI: B-47136487609A06R
Reference: S11004, S11008, S11009
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE 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

Eclipse PLUS

Eclipse PLUS Urine Control Solution

IVD generalIVDDNo longer on the marketHuman tissuesNear-patient testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BURS3Q
Basic UDI-DI: B-47136487608BURS3Q
Reference: S5800401 S5800402
EMDN: W010106020601
EMDN description: URINE TESTING 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

Eclipse PLUS

Eclipse PLUS Creatinine Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BCRTYV
Basic UDI-DI: B-47136487608BCRTYV
Reference: S5641012 S5641013
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
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

Eclipse PLUS

Eclipse PLUS ACR Reagent Kit

IVD generalIVDDNo longer on the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608BACRT2W
Basic UDI-DI: B-47136487608BACRT2W
Reference: S5641014 S5641015
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
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

Eclipse PLUS

Eclipse PLUS Multi-Purpose Analyzer

IVD generalIVDDNo longer on the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487608B06P
Basic UDI-DI: B-47136487608B06P
Reference: S35010
EMDN: W010106020601
EMDN description: URINE TESTING 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