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176 device results listed.

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CFΔ Collection System

CTL1

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000080
Basic UDI-DI: 86992260CTL1(40)TV
Reference: CTL1
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

06974235033512

MA-500 and CM series urinalysis system

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: Changchun Medicside Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000022835
UDI-DI: 06974235033512
Basic UDI-DI: 697423503UMA0002JT
Reference: 410202004
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 15:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974235033499

MA-500 and CM series urinalysis system

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingProfessional testingReagentSingle use

Manufacturer: Changchun Medicside Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000022835
UDI-DI: 06974235033499
Basic UDI-DI: 697423503UMA0001JR
Reference: 410201003
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 15:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974235033376

CA-500 and CM series urinalysis system

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Changchun Medicside Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000022835
UDI-DI: 06974235033376
Basic UDI-DI: 697423503UCA0005EX
Reference: 410104007
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 15:46

Manufacturer products Authorised representative products Authorised representative actors View details

Hb A1c CAPILLARY CALIBRATORS (5x2)

IVD Class CNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360047569
Basic UDI-DI: 3607364755BUFD
Reference: 4756
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 03:34

Manufacturer products View details

C-PEPTIDE CALIBRATOR

C-PEPTIDE

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309171897
Basic UDI-DI: 5204309000076PB
Reference: 1478-1293
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:54

Manufacturer products View details

LYSOZYME CALIBRATOR

LYSOZYME

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309125401
Basic UDI-DI: 5204309000089PL
Reference: 1478-1920
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

HDL-C Calibrator

999-73391, 995-73491, 993-73291

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165011
Basic UDI-DI: 498748114987481165028Z3
Reference: 993-73291
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

ClinCal® Serum Calibrator Set lyophilised, for CDT

Serum Calibrator & Serum Control for CDT

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: 04049195210135
Basic UDI-DI: 4049195CDTCTRLV8
Reference: 21013
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:57

Manufacturer products View details

ABX Pentra LDL Cal

A11A01678

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005255
Basic UDI-DI: 361023pentra_ldl_calKD
Reference: A11A01678
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:56

Manufacturer products View details

ABX Pentra HDL Cal

A11A01647

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005095
Basic UDI-DI: 361023pentra_hdl_calH9
Reference: A11A01647
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:56

Manufacturer products View details

CK-MB Calibrator

ODR30034

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080891
Basic UDI-DI: 150995902ODR30034J4
Reference: ODR30034
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:45

Manufacturer products View details

LDL Cholesterol Calibrator

ODC0012

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070373
Basic UDI-DI: 150995902ODC00128N
Reference: ODC0012
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

HDL Cholesterol Calibrator

ODC0011

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070366
Basic UDI-DI: 150995902ODC00118L
Reference: ODC0011
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:44

Manufacturer products View details

L-Type HDL-C Reagent 1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165028
Basic UDI-DI: 498748114987481165028Z3
Reference: 999-73391
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

L-Type HDL-C Reagent 2

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481165035
Basic UDI-DI: 498748114987481165028Z3
Reference: 995-73491
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

ReferrIL CK-MB

CK-MB

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426950452409
Basic UDI-DI: 842695045180884
Reference: 0018258100
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:24

Manufacturer products View details

Pancreatic Amylase Control

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115346
Basic UDI-DI: 69449040AB710000547
Reference: 105-054862-00
EMDN: W0101050302
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic Amylase Kit (Immunoinhibition-EPS Method)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115353
Basic UDI-DI: 69449040AB710000547
Reference: 105-054855-00
EMDN: W0101050302
EMDN description: AMYLASE - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic Amylase Kit (Immunoinhibition-EPS Method)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115391
Basic UDI-DI: 69449040AB710000547
Reference: 105-054857-00
EMDN: W0101050302
EMDN description: AMYLASE - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details