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241 device results listed.

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Atellica CH ENZ 1 Calibrator (ENZ 1 CAL)

IVDR_67_TTN_DUB-C_B_REAG_ENZ 1 CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597225
Basic UDI-DI: 0405686901704VM
Reference: 11099317
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® Special Protein Calibrator

IVDR_67_GLA_DUB-C_B_REAG_SP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005190
Basic UDI-DI: 0405686901189VR
Reference: 10445028
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH CHEM III Calibrator (CHEM III CAL)

IVDR_67_TTN_DUB-C_B_REAG_CHEM III_Cal

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597379
Basic UDI-DI: 0405686900777W9
Reference: 11099335
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH A‑LYTE IMT Standard A

IVDR_67_TTN_DUB-C_C_REAG_IMT Standard A

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595740
Basic UDI-DI: 0405686900823VP
Reference: 11099304
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH A‑LYTE IMT Standard B + Salt Bridge

IVDR_67_TTN_DUB-C_C_REAG_IMT Standard B + Salt Bridge

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595719
Basic UDI-DI: 0405686900824VR
Reference: 11099306
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Revogene® Check

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Meridian Bioscience Inc.
Manufacturer SRN: US-MF-000044096
UDI-DI: 00840733103285
Basic UDI-DI: 008407331REVOGENECLA002TH
Reference: 610220
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: Meridian Bioscience Europe S.r.l.
Last updated: 15.07.2026 22:25

Manufacturer products Authorised representative products Authorised representative actors View details

MULTICALIBRATORE

FCC40-2-2

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: FUTURLAB S.R.L.
Manufacturer SRN: IT-MF-000046539
UDI-DI: D-MULTICALIBRATOREUG
Basic UDI-DI: B-MULTICALIBRATOREUG
Reference: FCC40-2-2
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 05:18

Manufacturer products View details

ClinCal® Urine Calibrator Set, lyophil., for Nicotine and Metabolites (Level 0 - 6)

Urine Calibrator Set for Nicotine and Metabolites

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS3013AS
Basic UDI-DI: B-MS3013AS
Reference: MS3013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:15

Manufacturer products View details

D-ECH0184999AA

Calibrator for Automatic System (Multi-Cal)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH0184999AA
Basic UDI-DI: B-ECH0184999AA
Reference: ECH0184999
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH0183999A3

Calibrator for Automatic System (Multi-Cal)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH0183999A3
Basic UDI-DI: B-ECH0183999A3
Reference: ECH0183999
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01829999U

Calibrator for Automatic System (Multi-Cal)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01829999U
Basic UDI-DI: B-ECH01829999U
Reference: ECH0182999
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01819999M

Calibrator for Automatic System (Multi-Cal)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01819999M
Basic UDI-DI: B-ECH01819999M
Reference: ECH0181999
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

Unicel DxC SYNCHRON Systems HDL Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-B23634UE
Basic UDI-DI: B-B23634UE
Reference: B23634
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

ClinCal® Urine Calibrator, lyophil., for Trace Elements

Urine Calibrator for Trace Elements

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9988DK
Basic UDI-DI: B-9988DK
Reference: 9988
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 20:59

Manufacturer products View details

ClinCal® Whole Blood Calibrator, lyophil., for Trace Elements

Whole Blood Calibrator for Trace Elements

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9943CV
Basic UDI-DI: B-9943CV
Reference: 9943
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 20:59

Manufacturer products View details

ClinCal® Urine Calibrator, lyophil., for Phenolic Compounds

Urine Calibrator for Phenolic Compounds

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9925CT
Basic UDI-DI: B-9925CT
Reference: 9925
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 20:59

Manufacturer products View details

ClinCal® Urine Calibrator, lyophil., for Occupational Medicine

Urine Calibrator for Occupational Medicine

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9922CM
Basic UDI-DI: B-9922CM
Reference: 9922
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 20:59

Manufacturer products View details

ClinCal® Serum Calibrator Set, lyophil., for Amiodarone and Desethylamiodarone (Level 0 - 3)

Serum Calibrator Set for Amiodarone and Desethylamiodarone

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-9909CV
Basic UDI-DI: B-9909CV
Reference: 9909
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 20:59

Manufacturer products View details

Vitamine B1/B6, set 6x High

Vitamin B1/B6

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: 87205897084266
Basic UDI-DI: B-87205897084266
Reference: VTB-01.3
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:23

Manufacturer products View details

Vitamine B1/B6, set 6x Medium

Vitamin B1/B6

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: 87205897084198
Basic UDI-DI: B-87205897084198
Reference: VTB-01.2
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:23

Manufacturer products View details