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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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03.08.2026 10:01

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I-MB-576

IVD generalIVDDOn the marketKitReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025461097
Basic UDI-DI: B-05425025461097
Reference: I-MB-576
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:47

Manufacturer products View details

I-ME-288

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460984
Basic UDI-DI: B-05425025460984
Reference: I-ME-288
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:47

Manufacturer products View details

I-MD-288

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460977
Basic UDI-DI: B-05425025460977
Reference: I-MD-288
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:47

Manufacturer products View details

I-MB-288

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460953
Basic UDI-DI: B-05425025460953
Reference: I-MB-288
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-KH-1920

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460816
Basic UDI-DI: B-05425025460816
Reference: E-KH-1920
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-KH-480

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460809
Basic UDI-DI: B-05425025460809
Reference: E-KH-480
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IX-1920

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460731
Basic UDI-DI: B-05425025460731
Reference: E-IX-1920
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IX-480

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460724
Basic UDI-DI: B-05425025460724
Reference: E-IX-480
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IX-480S

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460717
Basic UDI-DI: B-05425025460717
Reference: E-IX-480S
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IZ-576

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460656
Basic UDI-DI: B-05425025460656
Reference: E-IZ-576
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IZ-288

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460649
Basic UDI-DI: B-05425025460649
Reference: E-IZ-288
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IY-1920

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460618
Basic UDI-DI: B-05425025460618
Reference: E-IY-1920
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IY-576

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460601
Basic UDI-DI: B-05425025460601
Reference: E-IY-576
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

E-IY-288

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zentech s.a.
Manufacturer SRN: BE-MF-000001650
UDI-DI: 05425025460595
Basic UDI-DI: B-05425025460595
Reference: E-IY-288
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

4SURE Level 2 𝝱-Ketone Control Solution 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: 05420040815641
Basic UDI-DI: B-05420040815641
Reference: ACS028
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 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

4SURE β -KETONE TEST STRIPS

𝝱 Ketone Test Strip

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

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815597
Basic UDI-DI: B-05420040815597
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
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