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01.08.2026 01:12

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566 device results listed.

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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

Multi Sera Calibrator

105-001144-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026046
Basic UDI-DI: 694490400046MultiCal***XZ
Reference: 105-001144-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Lipids Calibrator

105-001128-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025889
Basic UDI-DI: 694490400046LipidsCal**VP
Reference: 105-001128-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS & GLUT RED CAL)

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273218831
Basic UDI-DI: 50552732BAGRCAL1565X
Reference: AGR10571
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products 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

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

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

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273201239
Basic UDI-DI: 50552732BDIHDCA02628
Reference: CH2673
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (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

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

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

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

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

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

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

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