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199 device results listed.

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ABX Pentra Reference 280mL

A11A01901

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005613
Basic UDI-DI: B-03610230005613
Reference: A11A01901
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Reference

A11A01719

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005446
Basic UDI-DI: B-03610230005446
Reference: A11A01719
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Standard 2

A11A01718

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005439
Basic UDI-DI: B-03610230005439
Reference: A11A01718
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Standard 1

A11A01717

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005422
Basic UDI-DI: B-03610230005422
Reference: A11A01717
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra Multical

A11A01652

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005125
Basic UDI-DI: B-03610230005125
Reference: A11A01652
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ISE Reagent Module

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778045074
Basic UDI-DI: 7798100041572570KY
Reference: 1572570
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

CM Series Reagent Module LT

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778045067
Basic UDI-DI: 7798100041008155GC
Reference: 1008155
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

CMD 600 Reagent Module LT

IVD Class AIVDR 2017/746No longer on the marketKitProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778006686
Basic UDI-DI: 7798100041009904HA
Reference: 1009904
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

Calibration Standard Solution

M-E01,M-E02

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873821911
Basic UDI-DI: 697287382M-E01M-E02BN
Reference: 10.40.000111
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Calibration Standard Solution

M-M01

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873821904
Basic UDI-DI: 697287382M-M01JT
Reference: 10.40.000109
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Calibration Standard Solution

M-EM1

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873821898
Basic UDI-DI: 697287382M-EM1L7
Reference: 10.40.000065
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

Calibration Standard Solution

ES I、ES II

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873820174
Basic UDI-DI: 697287382ES5P
Reference: /
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

06935740733694

Multiple biochemical calibrators

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740733694
Basic UDI-DI: 69357407ICAS000034AX
Reference: /
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Calibrator 2 & 3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153840357
Basic UDI-DI: 6438153BU00136BT
Reference: 984035
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:08

Manufacturer products View details

ISE Calibrator 4

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153840340
Basic UDI-DI: 6438153BU00149C4
Reference: 984034
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:08

Manufacturer products View details

eCal

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153818301
Basic UDI-DI: 6438153BU00054BQ
Reference: 981830
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:07

Manufacturer products View details

HDL-LDL Calibrator

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816574
Basic UDI-DI: 6438153BU00132BK
Reference: 981657
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:06

Manufacturer products View details

INDIKO ISE Calibrator 1

ISE Calibrator 1

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004070
Basic UDI-DI: 6438153BU00135BR
Reference: 984032
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

05902643962217

BioCal (4x3 ml)

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962217
Basic UDI-DI: 59026439CBCH803BN
Reference: 1-803-0012
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details

05902643962187

Kalibrator CK-MB

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643962187
Basic UDI-DI: 59026439CBCH781C5
Reference: 1-781-0001
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Poland
Authorised representative: -
Last updated: 02.07.2026 05:28

Manufacturer products View details