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184 device results listed.

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CORMAY BILE ACIDS CONTROLS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651498
Basic UDI-DI: B-05907514651498
Reference: 5-149
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

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

URINE LOW OSMOLALITY CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273220377
Basic UDI-DI: 50552732BLOOSMC160RD
Reference: UC10650
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:14

Manufacturer products View details

sLDL CONTROL LEVEL 1 (sLDL CONTROL 1)

sLDL CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273209075
Basic UDI-DI: 50552732BSLDLCL099K6
Reference: LE5013
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

CK-MB Control Serum Level 2

ODR30036

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080914
Basic UDI-DI: 150995902ODR30036J8
Reference: ODR30036
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

CK-MB Control Serum Level 1

ODR30035

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080907
Basic UDI-DI: 150995902ODR30035J6
Reference: ODR30035
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

HDL/LDL Cholesterol Control Serum

ODC0005

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070304
Basic UDI-DI: 150995902ODC00058R
Reference: ODC0005
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:31

Manufacturer products View details

Adams CONTROL A1C

IVD Class CIVDR 2017/746Not intended for EU marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044253
Basic UDI-DI: 4987486BC0109344H8
Reference: 109344
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: ARKRAY Europe, B.V.
Last updated: 29.07.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

09120132230036

Control-Set: (DBS Control-Set – Level I, II, III for Lyso Triplex)

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testing

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230036
Basic UDI-DI: 1912013223A290-012VR
Reference: A290-012
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 26.07.2026 18:08

Manufacturer products View details

PROTEIN u&csf Control

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673288211
Basic UDI-DI: B-08431673288211
Reference: 1002451
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

Rheumatism ClinChem Control

AutoChem B801

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012420
Basic UDI-DI: B-06942253012420
Reference: 360113FSQ0Q21
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatism ClinChem Control

AutoChem B801

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012383
Basic UDI-DI: B-06942253012383
Reference: 360113FSQ0Q11
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMM ClinChem Control

AutoChem B801

IVD generalIVDDNo longer on the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012161
Basic UDI-DI: B-06942253012161
Reference: 360113MMQ9Q21
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMM ClinChem Control

AutoChem B801

IVD generalIVDDNo longer on the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253012123
Basic UDI-DI: B-06942253012123
Reference: 360113MMQ9Q11
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 23.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-D16525VC

N/A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-D16525VC
Basic UDI-DI: B-D16525VC
Reference: D16525
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 17.07.2026 04:58

Manufacturer products View details

D-D16525SVQ4

N/A

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-D16525SVQ4
Basic UDI-DI: B-D16525SVQ4
Reference: D16525SV
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 17.07.2026 04:58

Manufacturer products View details

Clonatest

i-TRA Turbidimetric Controls

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873309134
Basic UDI-DI: B-84352873309134
Reference: 3953010
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:34

Manufacturer products View details

Clonatest

i-FOB Turbidimetric Controls

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873307246
Basic UDI-DI: B-84352873307246
Reference: CT39005
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:33

Manufacturer products View details

cromatest

i-FOB Turbidimetric

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873307215
Basic UDI-DI: B-84352873307215
Reference: 3900040
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:33

Manufacturer products View details