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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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BCA-1000 Automatic Blood Coagulation Analyzer

BCA-1000 BCA-3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515001
Basic UDI-DI: 69257945W0202020102D0KU
Reference: 3009736
EMDN: -
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-1600

CS-1300B CS-1600

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504883
Basic UDI-DI: 69257945W0201010103D0JR
Reference: 3019011
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-600B

CS-600B CS-650 CS-680 CS-1200

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504647
Basic UDI-DI: 69257945W0201010102D0JL
Reference: 3000085
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

CS-T240

DR-7000D CS-T180 CS-T240 CS-T240Plus CS-300B CS-400 CS-480

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504579
Basic UDI-DI: 69257945W0201010101D0JF
Reference: 3000103
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Spain
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Probe Cleanser(BCC-3000)

Hematology Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501684
Basic UDI-DI: 69257945W0103010105R0LU
Reference: 3002433
EMDN: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

H-100

H-100,H-500,HC-300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794501295
Basic UDI-DI: 69257945W020101020102D0B3
Reference: 3000068
EMDN: -
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 09:33

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×10 + 1 CPU card (H12-800MA)