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4SURE Level 1 KETONE CONTROL SOLUTION

𝝱 Ketone Control Solution

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815634
Basic UDI-DI: B-05420040815634
Reference: ACS027
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 3 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815627
Basic UDI-DI: B-05420040815627
Reference: ACS019
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 2 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815610
Basic UDI-DI: B-05420040815610
Reference: ACS018
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE Level 1 Blood Glucose Control Solution

Blood Glucose Control Solution

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815603
Basic UDI-DI: B-05420040815603
Reference: ACS017
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator

HT001S

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101711
Basic UDI-DI: B-05404035101711
Reference: HT001S
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

HbA1c Control

HT001C

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101704
Basic UDI-DI: B-05404035101704
Reference: HT001C
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

Hemoglobin Calibrator

HBS02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101629
Basic UDI-DI: B-05404035101629
Reference: HBS02
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

HDL/LDL Calibrator

HBC11

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101438
Basic UDI-DI: B-05404035101438
Reference: HBC11
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

Biochemistry Quality Set

HBC123

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101445
Basic UDI-DI: B-05404035101445
Reference: HBC123
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

HDL/LDL Control

HBC10

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101421
Basic UDI-DI: B-05404035101421
Reference: HBC10
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

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CK (NAC & MB) Control

HBC08

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101414
Basic UDI-DI: B-05404035101414
Reference: HBC08
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

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Biochemistry Calibrator Specific

HBC03-S

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101407
Basic UDI-DI: B-05404035101407
Reference: HBC03-S
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Biochemistry Calibrator

HBC03

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101391
Basic UDI-DI: B-05404035101391
Reference: HBC03
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Biochemistry Pathological Control Specific

HBC02-S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101384
Basic UDI-DI: B-05404035101384
Reference: HBC02-S
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Biochemistry Pathological Control

HBC02

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101377
Basic UDI-DI: B-05404035101377
Reference: HBC02
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Biochemistry Normal Control Specific

HBC01-S

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101360
Basic UDI-DI: B-05404035101360
Reference: HBC01-S
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

Biochemistry Normal Control

HBC01

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101353
Basic UDI-DI: B-05404035101353
Reference: HBC01
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:35

Manufacturer products View details

04980679110353

EX-Ca

IVD generalIVDDOn the marketReagent

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679110353
Basic UDI-DI: B-04980679110353
Reference: J11035
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

04980679110346

EX-Ca

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679110346
Basic UDI-DI: B-04980679110346
Reference: J11034
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details

04980679110339

Standard solution 2

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: JOKOH CO.,LTD.
Manufacturer SRN: JP-MF-000025161
UDI-DI: 04980679110339
Basic UDI-DI: B-04980679110339
Reference: J11033
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 14:26

Manufacturer products Authorised representative products Authorised representative actors View details