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223 device results listed.

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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

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 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 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 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 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 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 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 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

HemoSmart GOLD

HemoSmart GOLD hemoglobin control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487606AHS2D
Basic UDI-DI: B-47136487606AHS2D
Reference: S5800112
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

HemoSmart GOLD

HemoSmart GOLD Hemoglobin Screening System

IVD self-testing devicesIVDDOn the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487606A06A
Basic UDI-DI: B-47136487606A06A
Reference: S25009, S25032, S25033
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

UASure II

UASure II uric acid control solution

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487605AUS3D
Basic UDI-DI: B-47136487605AUS3D
Reference: S5800386
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

UASure II

UASure II/ UASure II Link Blood Uric Acid Monitoring System

IVD self-testing devicesIVDDOn the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487605A065
Basic UDI-DI: B-47136487605A065
Reference: S95050, S95056, S95055, S95057
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Wellion AMADEUS

Wellion AMADEUS Control Solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C3SY3
Basic UDI-DI: B-47136487603C3SY3
Reference: S5800475, S5800476, S5800477
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus 5

Contrex Plus 5 Glucose Control Solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C1SXV
Basic UDI-DI: B-47136487603C1SXV
Reference: S5800301 S5800303 S5800459 S5800460 S5800461
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Advance II

GlucoSure Advance II Blood Glucose Monitoring System

IVD Annex II List BIVDDOn the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603C163
Basic UDI-DI: B-47136487603C163
Reference: S70335 S70350 S70512 S70513 S70514
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus 6

Contrex Plus 6 Glucose Control Solution

IVD generalIVDDNo longer on the marketNear-patient testingReagent

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B1SXQ
Basic UDI-DI: B-47136487603B1SXQ
Reference: S5800403 S5800404 S5800405
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details