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89 device results listed.

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CYBOW 12AC

CYBOW Series

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786PROCYU7
Basic UDI-DI: B-KR-MF-000015786PROCYU7
Reference: 4B04
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

ComboStik 13

ComboStik Series

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786PROCSTT
Basic UDI-DI: B-KR-MF-000015786PROCSTT
Reference: 2C04
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

DUS 12AC

DUS Series

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786DUSelfPN
Basic UDI-DI: B-KR-MF-000015786DUSelfPN
Reference: 8B04/8B14/8A24/8034/8044/8854/8364/8174/8184/8194/81A4
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

UriDoctor 11

CYBOW Series

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786CYSelfQM
Basic UDI-DI: B-KR-MF-000015786CYSelfQM
Reference: 1AN4
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

ComboStik 11

ComboStik Series

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786CSSelfNK
Basic UDI-DI: B-KR-MF-000015786CSSelfNK
Reference: 1964 / 1AD8/1AZ4/10Y4/15F4/15P1/14I0P/14X0P/12E8/1348/1204/1314
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

IDIR

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SKILLCELL
Manufacturer SRN: FR-MF-000024570
UDI-DI: D-IDIRMG
Basic UDI-DI: B-IDIRMG
Reference: SKC-PDT-001
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: France
Authorised representative: -
Last updated: 14.07.2026 01:05

Manufacturer products View details

06979359840008

ETest4100-01

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: JiangSu ETest Medical Electronic Technology Co Ltd.
Manufacturer SRN: CN-MF-000050551
UDI-DI: 06979359840008
Basic UDI-DI: B-06979359840008
Reference: ETest4100-01
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 02:39

Manufacturer products Authorised representative products Authorised representative actors View details

06975808410198

Creatinine, Microalbumin in Urine Assay kit (Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044320
UDI-DI: 06975808410198
Basic UDI-DI: B-06975808410198
Reference: 1 test/box
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 00:11

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Dry Chemistry Strip

C-14

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361351
Basic UDI-DI: B-06974735361351
Reference: C-14
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Dry Chemistry Strip

C-12

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361344
Basic UDI-DI: B-06974735361344
Reference: C-12
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Reagent Strips

KU-14A

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360330
Basic UDI-DI: B-06974735360330
Reference: KU-14A
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Urine Reagent Strips

KU-12B

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360323
Basic UDI-DI: B-06974735360323
Reference: KU-12B
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565509

24 samples/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565509
Basic UDI-DI: B-06974541565509
Reference: PR2024-UT01
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

DUS 7

DUS Series

IVD Class BIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: 08806141303275
Basic UDI-DI: 88061413US33D0JN
Reference: 3784
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:42

Manufacturer products Authorised representative products Authorised representative actors View details

ComboStik 3

ComboStik Series

IVD Class BIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: 08806141302698
Basic UDI-DI: 88061413US32D0JH
Reference: 2304
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

08806141302223

CYBOW Series

IVD Class BIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: 08806141302223
Basic UDI-DI: 88061413US31D0JC
Reference: 4C14
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

KOWACZ ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142250403
Basic UDI-DI: 859514221823082
Reference: 18230-11000
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:55

Manufacturer products View details

EHRLICH-UROBILINOGEN ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142233116
Basic UDI-DI: 859514221343079
Reference: 13430-11000
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:54

Manufacturer products View details

06941967217626

Wash Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217626
Basic UDI-DI: 69732628600045ZU
Reference: 01.09.1F.01.13.11
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967217619

Cleanser

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217619
Basic UDI-DI: 69732628600044ZS
Reference: 01.09.1F.01.13.23
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details