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134 device results listed.

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H series urine analyzer Control liquid for Turbidity

8ml/vial（200NTU）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504210
Basic UDI-DI: B-06925794504210
Reference: 232030104201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Calibration liquid for Turbidity

8ml/vial（400NTU）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504203
Basic UDI-DI: B-06925794504203
Reference: 232030104203
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 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Blue）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504197
Basic UDI-DI: B-06925794504197
Reference: 232030103203
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Green）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504180
Basic UDI-DI: B-06925794504180
Reference: 232030103202
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Red）

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794504173
Basic UDI-DI: B-06925794504173
Reference: 232030103201
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218869

Focusing Fluid

IVD Class AIVDR 2017/746On the marketAnimal tissuesReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218869
Basic UDI-DI: 69732628600303ZT
Reference: 01.09.1F.01.09.03
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218906

Focusing Fluid

IVD Class AIVDR 2017/746On the marketAnimal tissuesReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218906
Basic UDI-DI: 69732628600303ZT
Reference: 01.09.1F.01.09.04
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218968

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218968
Basic UDI-DI: 697326286001982R
Reference: 01.09.1F.01.10.04
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 03.08.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218951

US-Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218951
Basic UDI-DI: 697326286001982R
Reference: 01.09.1F.01.10.05
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 03.08.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Calibrator

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053068581
Basic UDI-DI: 69449040AB760000364
Reference: 105-043513-00
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C093NG

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C093NG
Basic UDI-DI: B-CNMF000014455-BF-C093NG
Reference: BF-C093
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C092NE

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C092NE
Basic UDI-DI: B-CNMF000014455-BF-C092NE
Reference: BF-C092
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C091NC

BF C09

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C091NC
Basic UDI-DI: B-CNMF000014455-BF-C091NC
Reference: BF-C091
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5193008Q3

Urinalysis Specific Gravity Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5193008Q3
Basic UDI-DI: B-HU5193008Q3
Reference: HU5193008
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5193002PP

Urine Analysis Color Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5193002PP
Basic UDI-DI: B-HU5193002PP
Reference: HU5193002
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5192008PU

Urinalysis Specific Gravity Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5192008PU
Basic UDI-DI: B-HU5192008PU
Reference: HU5192008
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5192004PL

Urinalysis Sediment Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5192004PL
Basic UDI-DI: B-HU5192004PL
Reference: HU5192004
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5192003PJ

Urinalysis Turbidity Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5192003PJ
Basic UDI-DI: B-HU5192003PJ
Reference: HU5192003
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5192002PG

Urine Analysis Color Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5192002PG
Basic UDI-DI: B-HU5192002PG
Reference: HU5192002
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-HU5191008PM

Urinalysis Specific Gravity Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-HU5191008PM
Basic UDI-DI: B-HU5191008PM
Reference: HU5191008
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:59

Manufacturer products Authorised representative products Authorised representative actors View details