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195 device results listed.

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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

GlucoSure POC Compact

GlucoSure POC Compact Blood Glucose Monitoring System

IVD generalIVDDNo longer on the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B15Y
Basic UDI-DI: B-47136487603B15Y
Reference: S70466, S70467
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

GlucoSure POC

GlucoSure POC Blood Glucose and Ketone Monitoring System

IVD generalIVDDNo longer on the marketInstrumentKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487603B05W
Basic UDI-DI: B-47136487603B05W
Reference: S84512, S84511
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

Contrex Plus 4

Contrex Plus 4 glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602AS7S
Basic UDI-DI: B-47136487602AS7S
Reference: S5800308, S5800153, S5800309, S5800154, S5800310, S5800155
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure HT Link

GlucoSure HT Link Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487602A15Q
Basic UDI-DI: B-47136487602A15Q
Reference: S70440, S70441, S70442
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

Contrex Plus III

Contrex Plus III glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601AS7M
Basic UDI-DI: B-47136487601AS7M
Reference: S5800091
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoSure Link

GlucoSure Link Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487601A15K
Basic UDI-DI: B-47136487601A15K
Reference: S70453, S70454, S70455
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

GlucoSure Autocode

GlucoSure Autocode 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-47136487601A05H
Basic UDI-DI: B-47136487601A05H
Reference: S70123, S70488
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-4-86X

HQ-A,HQ 02,HQ 03

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-86X
Basic UDI-DI: B-4-86X
Reference: /
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details