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RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 2

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingSingle use

Manufacturer: Bionostics
Manufacturer SRN: US-MF-000041075
UDI-DI: 10851290002420
Basic UDI-DI: B-10851290002420
Reference: CC527-level 2
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 11.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- level 1

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingSingle use

Manufacturer: Bionostics
Manufacturer SRN: US-MF-000041075
UDI-DI: 10851290002413
Basic UDI-DI: B-10851290002413
Reference: CC527-level 1
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 11.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

A1C HD CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106959NU
Basic UDI-DI: B-106959NU
Reference: 106959
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

OSMO STATION Control Solution Set

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-106342MD
Basic UDI-DI: B-106342MD
Reference: 106342
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

CALIBRATOR 90

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-105730MK
Basic UDI-DI: B-105730MK
Reference: 105730
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:28

Manufacturer products Authorised representative products Authorised representative actors View details

ClinChek® Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyzer), Level I, II

Plasma Control for Amino Acids (by Amino Acid Analyzer)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-10282EX
Basic UDI-DI: B-10282EX
Reference: 10282
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 00:58

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ClinCal® Plasma Calibrator, lyophil., for Amino Acids (by Amino Acid Analyzer (AAA))

Plasma Calibrator for Amino Acids (by Amino Acid Analyzer)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-10213EC
Basic UDI-DI: B-10213EC
Reference: 10213
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 00:56

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CALIBRATOR Lite

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101714LR
Basic UDI-DI: B-101714LR
Reference: 101714
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:48

Manufacturer products Authorised representative products Authorised representative actors View details

Cascadion™ SM Immunosuppressants Panel Internal Standard