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23.09.2026 19:29

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230 device results listed.

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Hemoglobin Calibrator

HBS02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035101629
Basic UDI-DI: B-05404035101629
Reference: HBS02
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 20:36

Manufacturer products View details

HbA1c Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984061986
Basic UDI-DI: 6970341680320200102JF
Reference: 0320200201
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

MR Serum Standard

105-001689-00、105-001690-00、105-001691-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026497
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001689-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

UIBC Calibrator

105-009265-00、105-004515-00、105-004516-00、105-002306-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031521
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-002306-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic Amylase Calibrator

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053115339
Basic UDI-DI: 69449040AB710000547
Reference: 105-053163-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

β-HB Calibrator

105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032375
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-002319-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

sLDL CALIBRATOR (sLDL CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273208436
Basic UDI-DI: 50552732BSLDLCR100K8
Reference: CH5050
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

MICROALBUMIN CALIBRATOR SERIES (mALB CAL)

MICROALBUMIN CALIBRATOR SERIES

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204520
Basic UDI-DI: 50552732BMALBCL08688
Reference: MA1567
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

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

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

Hb A1c CAPILLARY CALIBRATORS (2)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360047552
Basic UDI-DI: 3607364755BUFD
Reference: 4755
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:09

Manufacturer products View details

Adams CALIBRATOR A1C

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

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044246
Basic UDI-DI: 4987486BC0109343H6
Reference: 109343
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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

Cromatest

Lipase Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873043090
Basic UDI-DI: B-84352873043090
Reference: 1943005
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 28.07.2026 00:59

Manufacturer products View details

Cromatest

HbA1c Turbidimetric Calibrators

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873306072
Basic UDI-DI: B-84352873306072
Reference: 3955015
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 25.07.2026 01:42

Manufacturer products View details

Hemoglobin A1c Calibrator

105-007857-00,105-007858-00, 105-007859-00, 105-007862-00

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904054032
Basic UDI-DI: 69449040XQSJ-003X******HJ
Reference: 105-007857-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Calibrator

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904054049
Basic UDI-DI: 69449040XQSJ-003X******HJ
Reference: 105-007858-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Control

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904054056
Basic UDI-DI: 69449040XQSJ-003X******HJ
Reference: 105-007859-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Control

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904054087
Basic UDI-DI: 69449040XQSJ-003X******HJ
Reference: 105-007862-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

KIT DE CALIBRADORES HbA1c

GLUCOHEMOGLOBINA AUTOMATICA (HbA1c), KIT CALIBRADORES

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155001994
Basic UDI-DI: B-18430155001994
Reference: 999720
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:48

Manufacturer products View details

Cromatest

Bilirubin Standard

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873010221
Basic UDI-DI: B-84352873010221
Reference: 1912005
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:36

Manufacturer products View details