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973 device results listed.

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Pine Smart Baby Diaper

IVD Class AIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingSingle use

Manufacturer: Arkan Grup Sağlık Ürünleri A.Ş.
Manufacturer SRN: TR-MF-000027138
UDI-DI: 08699096963676
Basic UDI-DI: 869909696PS9Y
Reference: PSMN.02-R-24
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 31.07.2026 23:31

Manufacturer products View details

Urinalysis Strips

100 strips/bottle×10 + 1 IC card (FUS-10)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 16925794573640
Basic UDI-DI: B-16925794573640
Reference: 231050101006
EMDN: W0101060205
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 22:54

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: 31.07.2026 21:30

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

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Determinand Cleaning Liquid

150mL/bottle, 500mL/bottle, 4×500mL/bottle

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202226625
Basic UDI-DI: 69422022W010106029901R0EG
Reference: 3024590
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning liquid (Concentrated type)

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577269
Basic UDI-DI: 69257945W0101060299R0QZ
Reference: 3019971
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Sediment Analyzer Reagent Diluent

Urinalysis Reagent

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794576477
Basic UDI-DI: 69257945W010106020302R0FD
Reference: 3007269
EMDN: W010106020302
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

CYDXStrips Urine 2GP

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100622
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-2GP
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:59

Manufacturer products View details

CYDXStrips Urine 2GK

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100615
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-2GK
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:50

Manufacturer products View details

Urine 2AC

Urine-2AC

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100646
Basic UDI-DI: 54040351URINE-2AC38
Reference: Urine-2AC
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

CYDXStrips Urine 10

Urine-10 - Urine-2GK - Urine-2GP - Urine-3

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100608
Basic UDI-DI: 54040351CYDXStripsWH
Reference: Urine-10
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:46

Manufacturer products View details

GHB Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DGHB-R102acro75
Basic UDI-DI: B-DGHB-R102acro75
Reference: DGHB-R102
EMDN: W0101060201
EMDN description: URINE SINGLE TEST STRIPS (INCL. TABLETS)
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Adulteration Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAT-111MY
Basic UDI-DI: B-DAT-111MY
Reference: DAT-111
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:30

Manufacturer products Authorised representative products Authorised representative actors View details

Pine Smart Baby Diaper