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Precipitation solution with internal standard for PEth from whole blood

IVD Class BIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: ARCHImedline GmbH
Manufacturer SRN: AT-MF-000037501
UDI-DI: 09120132230173
Basic UDI-DI: 1912013223A371-010VP
Reference: A371-010
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 21:08

Manufacturer products View details

ISE Reference Solution Urine Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4US3008P
Basic UDI-DI: B-4US3008P
Reference: 4US300
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 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

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

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

ISE blood sample calibrator

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261503
Basic UDI-DI: B-06942202261503
Reference: 232030412202
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
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 Urine Calibrator

Level4: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247293
Basic UDI-DI: B-06942202247293
Reference: 3011950
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level3: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247286
Basic UDI-DI: B-06942202247286
Reference: 3012079
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level2: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247279
Basic UDI-DI: B-06942202247279
Reference: 3011989
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Calibrator

Level1: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247262
Basic UDI-DI: B-06942202247262
Reference: 3012148
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemical Calibration Serum

Level2: 4×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235054
Basic UDI-DI: B-06942202235054
Reference: 3025740
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 20×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235023
Basic UDI-DI: B-06942202235023
Reference: 3025731
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 15×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235016
Basic UDI-DI: B-06942202235016
Reference: 3025723
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 10×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202235009
Basic UDI-DI: B-06942202235009
Reference: 3025734
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 8×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202234996
Basic UDI-DI: B-06942202234996
Reference: 3025722
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 6×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202234989
Basic UDI-DI: B-06942202234989
Reference: 3025724
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 4×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202234972
Basic UDI-DI: B-06942202234972
Reference: 3025736
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

Level 2: 3×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202234965
Basic UDI-DI: B-06942202234965
Reference: 3025728
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 17:00

Manufacturer products Authorised representative products Authorised representative actors View details

Clinical Chemistry Calibrator

IVD generalNot specifiedOn the market

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202234958
Basic UDI-DI: B-06942202234958
Reference: 3025732
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details