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S.G. Calibrator H

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100672LT
Basic UDI-DI: B-100672LT
Reference: 100672
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Germany
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

PRIMA HOME TEST

100058-x

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-100058-3CSXU
Basic UDI-DI: B-100058-3CSXU
Reference: 100058-3CS
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrator solution for urine analyzer

Quality control solution for urine analyzer

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-66C
Basic UDI-DI: B-1-66C
Reference: /
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Quality control solution for urine analyzer

UNAMAX SG Control，UNAMAX COLOR Control，UNAMAX TURBIDITY Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-56A
Basic UDI-DI: B-1-56A
Reference: /
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control Solution for Urine Analyzer

UNAMAX U11 Control，UNAMAX U14 Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-468
Basic UDI-DI: B-1-468
Reference: /
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine reagent strips

LabUSticks 10G，LabUSticks 11G，LabUSticks 14G

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-264
Basic UDI-DI: B-1-264
Reference: /
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine reagent strips

LabUSticks 10A

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-366
Basic UDI-DI: B-1-366
Reference: /
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine reagent strips

LabUSticks 11F，LabUSticks 12F，LabUSticks 14F

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: D-1-162
Basic UDI-DI: B-1-162
Reference: /
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC Urinalysis Reagent Strips (10 Parameters)

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616053
Basic UDI-DI: B-08697962616053
Reference: SU10-101
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Greece
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

RapidFor™ UTI Strip Test (Leukocyte + Nitrite)

VMD106

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595036761
Basic UDI-DI: B-08684595036761
Reference: VMD106
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

RapidFor™ UTI Strip Test (Leukocyte + Nitrite)

VMD106

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032275
Basic UDI-DI: B-08684595032275
Reference: VMD106
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

Urine Protein (uPRO)

Urine Protein 80 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555612298
Basic UDI-DI: B-08683555612298
Reference: B22300
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:30

Manufacturer products View details

Urine Protein

Urine Protein 240 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555611079
Basic UDI-DI: B-08683555611079
Reference: B21302
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:27

Manufacturer products View details

Urine Protein

Urine Protein 108 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555611062
Basic UDI-DI: B-08683555611062
Reference: B21301
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:27

Manufacturer products View details

Urine Protein

Urine Protein 216 mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555611055
Basic UDI-DI: B-08683555611055
Reference: B21300
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:27

Manufacturer products View details

Prueba de infecciones del tracto urinario

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551156
Basic UDI-DI: B-08436592551156
Reference: U031-11
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 08.07.2026 00:51

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Strip

Urine Strip 10

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07798100044255
Basic UDI-DI: B-07798100044255
Reference: 1920140
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:11

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Strip

Urine Strip 10

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778047597
Basic UDI-DI: B-07791778047597
Reference: 1920142
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Strip

Urine Strip 10

IVD generalIVDDNo longer on the marketProfessional testingReagent

Manufacturer: Wiener Laboratorios SAIC
Manufacturer SRN: AR-MF-000023605
UDI-DI: 07791778046125
Basic UDI-DI: B-07791778046125
Reference: 1920141
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Tract Infections Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 07350123504576
Basic UDI-DI: B-07350123504576
Reference: U031-04H
EMDN: W0101060204
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details