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ISE Reference Solution Serum Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4SS3007Z
Basic UDI-DI: B-4SS3007Z
Reference: 4SS300
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Reference Solution Serum Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4SC2GX
Basic UDI-DI: B-4SC2GX
Reference: 4SC2
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADA, KIT DE CONTROL

ADENOSINA DESAMINASA CONTROLES

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155008863
Basic UDI-DI: B-18430155008863
Reference: 993240
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:47

Manufacturer products View details

FUJI DRI-CHEM ELECTROLYTE CONTROL QE

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: FUJIFILM Corporation
Manufacturer SRN: JP-MF-000010401
UDI-DI: 14902520282672
Basic UDI-DI: B-14902520282672
Reference: 14902520282672
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Netherlands
Authorised representative: FUJIFILM Healthcare Europe GmbH
Last updated: 04.08.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

BILIRUBIN T CALIBRATOR

IVD generalIVDDOn the marketAnimal tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673022501
Basic UDI-DI: B-08431673022501
Reference: 1002250
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 04:15

Manufacturer products View details

TruSight™ Oncology DNA Control v2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020873
Basic UDI-DI: 0081627002RNADNACTRLMV
Reference: 20090155
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261770
Basic UDI-DI: B-06942202261770
Reference: 232021102013
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）

Calibration sample: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261763
Basic UDI-DI: B-06942202261763
Reference: 232021002011
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:30

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemical Quality Control Serum

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261572
Basic UDI-DI: B-06942202261572
Reference: 232030415202
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

Low: Dissolved liquid: 4mL×5bottles，Freeze-dried powder: 0.18g×5bottles