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

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SLX-120

SLX-120 Lipid and Blood Glucose Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175039883
Basic UDI-DI: B-06934175039883
Reference: 3G001DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Portugal
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Smart

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037681
Basic UDI-DI: B-06934175037681
Reference: 2J003DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

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Safe-Accu2

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037421
Basic UDI-DI: B-06934175037421
Reference: 5D001DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037391
Basic UDI-DI: B-06934175037391
Reference: 1N002DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

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Safe AQ UG

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175026777
Basic UDI-DI: B-06934175026777
Reference: 1V001DD
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

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Safe AQ Voice

IVD Annex II List BIVDDOn the marketInstrumentProfessional testingSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175012480
Basic UDI-DI: B-06934175012480
Reference: 2K003DD
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

06930317800892

WD240

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer SRN: CN-MF-000001133
UDI-DI: 06930317800892
Basic UDI-DI: B-06930317800892
Reference: WD240
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-1800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794594334
Basic UDI-DI: B-06925794594334
Reference: H-1800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-1800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794594327
Basic UDI-DI: B-06925794594327
Reference: H-1800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-1800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794594310
Basic UDI-DI: B-06925794594310
Reference: H-1800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-1800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794594303
Basic UDI-DI: B-06925794594303
Reference: H-1800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

H-1800

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794594297
Basic UDI-DI: B-06925794594297
Reference: H-1800
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:51

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Chemistry Analyzer

CS-1600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794581600
Basic UDI-DI: B-06925794581600
Reference: CS-1600
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Chemistry Analyzer

CS-1600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794581587
Basic UDI-DI: B-06925794581587
Reference: CS-1600
EMDN: W0201010107
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:44

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module + 1 computer & cart

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577115
Basic UDI-DI: B-06925794577115
Reference: 1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module etc
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Integrated System

CSM-9000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577108
Basic UDI-DI: B-06925794577108
Reference: CSM-9000
EMDN: W0201030103
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput > 2000 test/h)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis System

MUS-3600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576460
Basic UDI-DI: B-06925794576460
Reference: MUS-3600
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis System

MUS-3600

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576453
Basic UDI-DI: B-06925794576453
Reference: MUS-3600
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Hybrid

FUS-3000Plus

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576323
Basic UDI-DI: B-06925794576323
Reference: FUS-3000Plus
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Hybrid

FUS-2000

IVD generalIVDDOn the marketInstrument

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576316
Basic UDI-DI: B-06925794576316
Reference: FUS-2000
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details