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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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BILIRUBIN T CALIBRATOR

No

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261527
Basic UDI-DI: B-06942202261527
Reference: 232030413204
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

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202261510
Basic UDI-DI: B-06942202261510
Reference: 232030413203
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 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 Control

Level3: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247323
Basic UDI-DI: B-06942202247323
Reference: 3011990
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Control

Level2: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247316
Basic UDI-DI: B-06942202247316
Reference: 3012119
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Urine Control

Level1: 1×5mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247309
Basic UDI-DI: B-06942202247309
Reference: 3012147
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 17:16

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

Lipid Control Serum

Level2: 3×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247255
Basic UDI-DI: B-06942202247255
Reference: 3003171
EMDN: W0101050202
EMDN description: LIPID CONTROLS
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

Lipid Control Serum

Level2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247248
Basic UDI-DI: B-06942202247248
Reference: 3003169
EMDN: W0101050202
EMDN description: LIPID CONTROLS
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

Lipid Control Serum

Level1: 3×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247231
Basic UDI-DI: B-06942202247231
Reference: 3003165
EMDN: W0101050202
EMDN description: LIPID CONTROLS
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

Lipid Control Serum

Level1: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247224
Basic UDI-DI: B-06942202247224
Reference: 3003163
EMDN: W0101050202
EMDN description: LIPID CONTROLS
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

Specific Protein Control Serum

Level2: 1×1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202247217
Basic UDI-DI: B-06942202247217
Reference: 3003157
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
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