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124 device results listed.

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HbA1c Control Material

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062044
Basic UDI-DI: 6970341680320200101JD
Reference: 0320200301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem A1c

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523440202
Basic UDI-DI: 539152344CHEM095R
Reference: HB000A
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: -
Last updated: 10.08.2026 23:22

Manufacturer products View details

Multichem A1c

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523440837
Basic UDI-DI: 539152344CHEM095R
Reference: HB001A
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

Multichem A1c

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523440844
Basic UDI-DI: 539152344CHEM095R
Reference: HB002A
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

Multichem A1c

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523440851
Basic UDI-DI: 539152344CHEM095R
Reference: HB000M
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

Multichem A1c

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Techno-path Manufacturing Ltd.
Manufacturer SRN: IE-MF-000001822
UDI-DI: 05391523441254
Basic UDI-DI: 539152344CHEM095R
Reference: 04V0610
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Authorised representative: -
Last updated: 10.08.2026 22:47

Manufacturer products View details

04560189283923

Hemoglobin A1c Control Set

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189283923
Basic UDI-DI: B-04560189283923
Reference: 0021974
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 07.08.2026 19:18

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCO TEST Plus Kontrolllösung hoch

Blood Glucose Control Solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04251575910478
Basic UDI-DI: B-04251575910478
Reference: TD-4912
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCO TEST DUO Kontrolllösung hoch

Blood Glucose Control Solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04251575910454
Basic UDI-DI: B-04251575910454
Reference: TD-4908
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

CORMAY HbA1c DIRECT CONTROLS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514643288
Basic UDI-DI: B-05907514643288
Reference: 4-328
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:05

Manufacturer products 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 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

ß-Ketone Control Solution L1

ß-Ketone control solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04713106024424
Basic UDI-DI: B-04713106024424
Reference: TD-4914
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

ß-Ketone Control Solution L2

ß-Ketone control solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04713106024431
Basic UDI-DI: B-04713106024431
Reference: TD-4915
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Control Solution L1

Total Cholesterol control solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04713106024400
Basic UDI-DI: B-04713106024400
Reference: TD-4919
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution,Normal

Blood Glucose Control Solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04710636649011
Basic UDI-DI: B-04710636649011
Reference: TD-4911
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution_B3

Blood Glucose Control Solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04710636643590
Basic UDI-DI: B-04710636643590
Reference: TD-4909
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution_W2

Blood Glucose Control Solution

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04710636643583
Basic UDI-DI: B-04710636643583
Reference: TD-4908
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details