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223 device results listed.

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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

D-4-36M

URIT GQ25

IVD self-testing devicesIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-4-36M
Basic UDI-DI: B-4-36M
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

TruReno

Lipid Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245035
Basic UDI-DI: B-15065026245035
Reference: TR10008
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

TruReno

Electrochemical control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245004
Basic UDI-DI: B-15065026245004
Reference: TR10005
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Finland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

TruGlyc

HbA1c control

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763808
Basic UDI-DI: B-15065023763808
Reference: TG10003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S Control Solution