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

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89 device results listed.

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Amplatz

Invasive Dilators and Dilator Sets for Fascial, Tract and Renal Dilation [Sheath and Dilator]

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002179677
Basic UDI-DI: 0827002CINC050-123_A5YR
Reference: VS-300016-ARI
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 13.08.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

16973356559779

Disposable Ureteral Access Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Shenzhen Trious Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000041398
UDI-DI: 16973356559779
Basic UDI-DI: 697335655205YWQG002G9
Reference: 205Y12F35
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: France
Authorised representative: Eunitor GmbH
Last updated: 10.08.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

16973356559786

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Shenzhen Trious Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000041398
UDI-DI: 16973356559786
Basic UDI-DI: 697335655205YWQG002G9
Reference: 205Y12F45
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 10.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

16973356559632

Disposable Ureteral Access Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Shenzhen Trious Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000041398
UDI-DI: 16973356559632
Basic UDI-DI: 697335655205YWQG002G9
Reference: 205W10F40
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: France
Authorised representative: Eunitor GmbH
Last updated: 10.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

16973356559649

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Shenzhen Trious Medical Technology Co., Ltd
Manufacturer SRN: CN-MF-000041398
UDI-DI: 16973356559649
Basic UDI-DI: 697335655205YWQG002G9
Reference: 205W10F50
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: Eunitor GmbH
Last updated: 10.08.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

U-FLEX URETERAL ACCESS SHEATH

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261015286
Basic UDI-DI: 081226101UAS012SH
Reference: UF14/12-38
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

U-FLEX URETERAL ACCESS SHEATH

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261019741
Basic UDI-DI: 081226101UAS012SH
Reference: UF11.5/9.5-35
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

U-FLEX URETERAL ACCESS SHEATH

Class INot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261019758
Basic UDI-DI: 081226101UAS012SH
Reference: UF11.5/9.5-45
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

08905516000785

Braided Shaft Catheter (Ureteral Access Sheath)

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Biorad Medisys Pvt Ltd
Manufacturer SRN: IN-MF-000013050
UDI-DI: 08905516000785
Basic UDI-DI: 890551604SZ
Reference: BUUAS0209528
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 01.08.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Amplatz

Amplatz Radiopaque TFE Sheath Use with Amplatz Dilator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002179646
Basic UDI-DI: 0827002CINC050-123_A5YR
Reference: VS-240016-ARI
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 30.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Amplatz

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002179844
Basic UDI-DI: 0827002CINC050-123_A5YR
Reference: VS-180016-ARI
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 30.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Amplatz

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002179769
Basic UDI-DI: 0827002CINC050-123_A5YR
Reference: VS-300030-ARI
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 30.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

U-Flex Ureteral Access Sheath

Class INot specifiedNo longer on the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261014968
Basic UDI-DI: 081226101UAS012SH
Reference: UF14/12-45
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Navigator™

Navigator UAS Family

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729429920
Basic UDI-DI: 01915060000000000000540N5
Reference: M0062502000
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

TPS PLUS 60

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096722
Basic UDI-DI: B-07290013096722
Reference: 792-1060
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

TPS PLUS 50

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096715
Basic UDI-DI: B-07290013096715
Reference: 792-1050
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

TPS PLUS 40

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096708
Basic UDI-DI: B-07290013096708
Reference: 792-1040
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

TPS PLUS 30

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096692
Basic UDI-DI: B-07290013096692
Reference: 792-1030
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

BUS-R-80

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096630
Basic UDI-DI: B-07290013096630
Reference: 791-1080
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:02

Manufacturer products Authorised representative products Authorised representative actors View details

RPS 30

Class IIbMDDOn the marketImplantableSingle useSterile

Manufacturer: Allium Ltd.
Manufacturer SRN: IL-MF-000009302
UDI-DI: 07290013096609
Basic UDI-DI: B-07290013096609
Reference: 793-0030
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 03:01

Manufacturer products Authorised representative products Authorised representative actors View details