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

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Urinary Tract Infections Test

Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105729
Basic UDI-DI: B-06936983105729
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Croatia
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ UG

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037919
Basic UDI-DI: B-06934175037919
Reference: 1V003DD
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
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 UG

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037902
Basic UDI-DI: B-06934175037902
Reference: 1V002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Spain
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

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037704
Basic UDI-DI: B-06934175037704
Reference: 2J002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

Safe-Accu2

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037438
Basic UDI-DI: B-06934175037438
Reference: 5D002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037407
Basic UDI-DI: B-06934175037407
Reference: 1N003DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Spain
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

SG-12 Blood Glucose Test Strip

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175033577
Basic UDI-DI: B-06934175033577
Reference: 3G003DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

LL-12 Lipid Test Strip

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175033447
Basic UDI-DI: B-06934175033447
Reference: 3G002DD
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
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

Blood Glucose Control Solution

Level 2

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175027293
Basic UDI-DI: B-06934175027293
Reference: 1A004DD
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
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

Blood Glucose Control Solution

Level 1

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175027286
Basic UDI-DI: B-06934175027286
Reference: 1A003DD
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
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 2

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175023745
Basic UDI-DI: B-06934175023745
Reference: 6934175023745
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 AQ pro Ⅰ

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175016747
Basic UDI-DI: B-06934175016747
Reference: 5Y002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 AQ pro I

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175016594
Basic UDI-DI: B-06934175016594
Reference: 5Y001DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

125mL

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794573933
Basic UDI-DI: B-06925794573933
Reference: 232030202201
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Standard Solution

125mL

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794573926
Basic UDI-DI: B-06925794573926
Reference: 232030201201
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Negative Control

125mL

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794573919
Basic UDI-DI: B-06925794573919
Reference: 232030207204
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Positive Control

125mL

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794573902
Basic UDI-DI: B-06925794573902
Reference: 232030207201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Turbidity

8ml/vial（700NTU）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794573803
Basic UDI-DI: B-06925794573803
Reference: 232030104202
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×6 + 1 CPU card (H14-Ca)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794522863
Basic UDI-DI: B-06925794522863
Reference: 231012401001
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Strips

100 strips/bottle×6 + 1 CPU card (H13-Cr)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794522856
Basic UDI-DI: B-06925794522856
Reference: 231010101001
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details