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EUDAMED Device Search

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

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01.08.2026 18:27

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132 device results listed.

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URS-11F

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Bioway Biological Technology Co., Ltd
Manufacturer SRN: CN-MF-000026464
UDI-DI: 06974410142084
Basic UDI-DI: B-06974410142084
Reference: URS-11F
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 19:07

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URS-12H

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Bioway Biological Technology Co., Ltd
Manufacturer SRN: CN-MF-000026464
UDI-DI: 06974410142053
Basic UDI-DI: B-06974410142053
Reference: URS-12H
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 19:07

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Urine Strip

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Bioway Biological Technology Co., Ltd
Manufacturer SRN: CN-MF-000026464
UDI-DI: 06974410142039
Basic UDI-DI: B-06974410142039
Reference: URS-12F
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Romania
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 19:07

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URS-10F

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Bioway Biological Technology Co., Ltd
Manufacturer SRN: CN-MF-000026464
UDI-DI: 06974410142022
Basic UDI-DI: B-06974410142022
Reference: URS-10F
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 19:07

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URS-10H

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Bioway Biological Technology Co., Ltd
Manufacturer SRN: CN-MF-000026464
UDI-DI: 06974410142015
Basic UDI-DI: B-06974410142015
Reference: URS-10H
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 19:07

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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

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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

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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

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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

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FEHLING II ROZTOK

FEHLING II ROZTOK

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142235011
Basic UDI-DI: 859514221377084
Reference: 13770-11000
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:54

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FEHLING I ROZTOK

FEHLING I ROZTOK

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testingReagentSingle use

Manufacturer: Ing. Petr Švec - PENTA s.r.o.
Manufacturer SRN: CZ-MF-000035988
UDI-DI: 08595142234915
Basic UDI-DI: 85951422137607Z
Reference: 13760-11000
EMDN: W01010902
EMDN description: URINE SEDIMENT TEST KIT (AUTOMATED)
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:54

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EHRLICH-UROBILINOGEN ROZTOK

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

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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

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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

Urinalysis Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217596
Basic UDI-DI: 69732628600043ZQ
Reference: 01.09.1F.01.12.05
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

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Sheath Fluid

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217572
Basic UDI-DI: 69732628600042ZN
Reference: 01.09.1F.01.11.12
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

UF- Fluorocell SF

UF- Fluorocell SF

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509062
Basic UDI-DI: 4987562UF-FluorocellSFMC
Reference: AV083519
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

UF- Fluorocell CR

UF- Fluorocell CR

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 14987562509055
Basic UDI-DI: 4987562UF-FluorocellCRLL
Reference: BW056982
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: 08806141304463
Basic UDI-DI: 88061413US31D0JC
Reference: 4B04
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: 08806141304470
Basic UDI-DI: 88061413US31D0JC
Reference: 0A94
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 28.06.2026 23:19

Manufacturer products Authorised representative products Authorised representative actors View details