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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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TruSight™ Oncology RNA Control v2

TruSight™ Oncology Controls v2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020866
Basic UDI-DI: 0081627002RNADNACTRLMV
Reference: 20090165
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 04.08.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

ISE Reference Solution Urine Control

ISE Reference Solution Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-4UC2H9
Basic UDI-DI: B-4UC2H9
Reference: 4UC2
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

ISE Reference Solution Serum Control

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

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

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 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 blood quality control

High: 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: 06942202230936
Basic UDI-DI: B-06942202230936
Reference: 3025280
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

High: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230929
Basic UDI-DI: B-06942202230929
Reference: 232030413201
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

Low: 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: 06942202230912
Basic UDI-DI: B-06942202230912
Reference: 3025268
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

ISE blood quality control

Low: Dissolved liquid: 4mL×1bottle，Freeze-dried powder: 0.18g×1bottle

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230905
Basic UDI-DI: B-06942202230905
Reference: 232030413202
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:59

Manufacturer products Authorised representative products Authorised representative actors View details

Level 2: 20×5mL

Level 2: 20×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230813
Basic UDI-DI: B-06942202230813
Reference: 3025197
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - 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

Clinical Chemistry Control

Level 2: 15×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230806
Basic UDI-DI: B-06942202230806
Reference: 3025178
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - 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

Clinical Chemistry Control

Level 2: 10×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230790
Basic UDI-DI: B-06942202230790
Reference: 3025177
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - 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

Clinical Chemistry Control

Level 2: 8×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230783
Basic UDI-DI: B-06942202230783
Reference: 3025212
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - 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

Clinical Chemistry Control

Level 2: 6×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230776
Basic UDI-DI: B-06942202230776
Reference: 3025221
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - 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

Clinical Chemistry Control

Level 2: 3×5mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202230769
Basic UDI-DI: B-06942202230769
Reference: 3025231
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:58

Manufacturer products Authorised representative products Authorised representative actors View details