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ALDOLASE CALIBRATION SERUM (ALS CAL)

ALDOLASE CALIBRATION SERUM

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273200089
Basic UDI-DI: 50552732BALSCAL0048P
Reference: AD5000
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

small dense LDL-Control Set

small dense LDL-Control Set

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503563088
Basic UDI-DI: 4987503sdLDLconPA
Reference: 08834105190
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

small dense LDL-Calibrator

small dense LDL-Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503563071
Basic UDI-DI: 4987503sdLDLcalMU
Reference: 08834091190
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

trister® Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128310609
Basic UDI-DI: 88061283AGM2100CD9
Reference: AGM-2100-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G01-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

G1 Advance Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340408
Basic UDI-DI: 88061283AGM4000CDQ
Reference: AGM-4000-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoSmart® Swing2 Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128340804
Basic UDI-DI: 88061283AGM4000CDQ
Reference: AGM-4000-C3-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G10-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

familyDr.™ Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351008
Basic UDI-DI: 88061283AGM513SCHX
Reference: AGM-513S-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G06-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

familyDr.™ BLE Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351107
Basic UDI-DI: 88061283ABM513SCFA
Reference: ABM-513S-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G11-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

VERI-Q PRO Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351800
Basic UDI-DI: 88061283AGM513SCHX
Reference: AGM-513S-C4-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G06-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

trister® P Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351909
Basic UDI-DI: 88061283AGM514PCHT
Reference: AGM-514P-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G07-06 · Rev. 02
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

trister® P BLE Control Solution

-

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128352005
Basic UDI-DI: 88061283ABM514PCF6
Reference: ABM-514P-C2-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: -
Safety summary (SSCP/SSP): AM-TD-G05-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

MICROPROTEIN Standard

MICROPROTEIN Standard

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700826026
Basic UDI-DI: 37017008PRTU04JP
Reference: PRTU-4020
EMDN: W0101050303
EMDN description: AQUEOUS STANDARDS (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:52

Manufacturer products View details

ISE CALIBRATORS

ISE CALIBRATORS

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700824008
Basic UDI-DI: 37017008ISCA049C
Reference: ISCA-0250
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

PROTEIN IP CALIBRATOR SET

PROTEIN IP CALIBRATOR SET

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700823308
Basic UDI-DI: 37017008IPRO04DS
Reference: IPRO-0043
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

HDL LDL CALIBRATOR

HDL LDL CALIBRATOR

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700821601
Basic UDI-DI: 37017008HLCA046J
Reference: HLCA-0041
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

ELITROL I

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700819400
Basic UDI-DI: 37017008CONT05AY
Reference: CONT-0060
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:50

Manufacturer products View details

CKMB-0900

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700818908
Basic UDI-DI: 37017008CKMB056K
Reference: CKMB-0900
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:50

Manufacturer products View details

ELICAL 2

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700817802
Basic UDI-DI: 37017008CALI043X
Reference: CALI-0550
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:50

Manufacturer products View details

ABX Pentra Ferritin Cal

A11A01619

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004852
Basic UDI-DI: 361023pentra_ferr_calZS
Reference: A11A01619
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)

MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (10x2)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360047675
Basic UDI-DI: 3607364767BUFW
Reference: 4767
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:09

Manufacturer products View details