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Ureteral Access Sheathes

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000008462
UDI-DI: 06941513223217
Basic UDI-DI: 697005757111HE
Reference: VDK-NSA-10350A-1
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Coloplast

Ureteral dilator

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Coloplast A/S
Manufacturer SRN: DK-MF-000025526
UDI-DI: 03600040975312
Basic UDI-DI: 57089326358428G
Reference: RBD010
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Austria
Authorised representative: -
Last updated: 23.07.2026 22:49

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Coloplast

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Coloplast A/S
Manufacturer SRN: DK-MF-000025526
UDI-DI: 03600040975343
Basic UDI-DI: 57089326358428G
Reference: RBD014
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 22:38

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Disposable Ureteral Access Sheaths

ZRH-NQG-9.5/10/11/12/14-130/280/350/400/450/500/600-(Y)

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.
Manufacturer SRN: CN-MF-000027760
UDI-DI: D-6979246722GD
Basic UDI-DI: B-6979246722GD
Reference: 1010
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:18

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Sahil Surgical (Pvt) Ltd

6485085

Class IMDR 2017/745On the marketReusable

Manufacturer: Sahil Surgical (Pvt.) Ltd
Manufacturer SRN: PK-MF-000047528
UDI-DI: 08964001697800
Basic UDI-DI: 89640016976485085U2
Reference: 6485085
EMDN: U03010201
EMDN description: URETHRAL DILATORS
First on market country: Spain
Authorised representative: KHANG BAO INTERNATIONAL KFT
Last updated: 16.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

Urethral Dilation Balloon Catheter With Coudé Tip

Urethral Dilation Balloon Catheter

Class IMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002178427
Basic UDI-DI: 0827002CINC050-124_BJA
Reference: UDBS-090029
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

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Ureteral Dilator Set Dilators With AQ® Hydrophilic Coating

Ureteral Dilator [With AQ® Hydrophilic Coating With Modified Taper; Set Dilators With AQ® Hydrophilic Coating; S~Curve® with AQ® Hydrophilic Coating]

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002173101
Basic UDI-DI: 0827002CINC050-124_A1YQ
Reference: AQ-076000
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Balloon Ureteral Dilator

Balloon Ureteral Dilator [Set]

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002142619
Basic UDI-DI: 0827002CINC050-124_B1YT
Reference: 010004
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

Manufacturer products Authorised representative products Authorised representative actors View details

Urethral Dilator Set

Dilator Set [Ureteral; Integral Filiform; Urethral; Tunner Pediatric Urethral]

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Cook Incorporated
Manufacturer SRN: US-MF-000003180
UDI-DI: 00827002141858
Basic UDI-DI: 0827002CINC050-124_A2YS
Reference: 073701
EMDN: U03010201
EMDN description: URETHRAL DILATORS
First on market country: Germany
Authorised representative: COOK MEDICAL EUROPE LIMITED
Last updated: 16.07.2026 04:44

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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

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ARMADA Dilators & Sets

Class IIaNot specifiedNo longer on the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261012605
Basic UDI-DI: 081226101DST010RV
Reference: NOT6/10
EMDN: U03010202
EMDN description: URETERAL DILATORS
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

UreTrack Ureteral Balloon Dilator

Class IIaNot specifiedOn the marketDirect markingSingle useSterile

Manufacturer: Allwin Medical Devices, Inc
Manufacturer SRN: US-MF-000011349
UDI-DI: 00812261012582
Basic UDI-DI: 081226101BDR009KX
Reference: UBD5/4
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Greece
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

UroMax Ultra™

UroMax Ultra Balloon Dilation Catheter

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729341109
Basic UDI-DI: 01915060000000000000532N6
Reference: M0062251000
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
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

08714729005421

Renal Dilators & Renal Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729005421
Basic UDI-DI: 01915060000000000000516N8
Reference: M0062601000
EMDN: U03010101
EMDN description: AMPLATZ CANNULAS FOR URINARY DILATION
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

08714729005322

URETERAL DILATORS

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729005322
Basic UDI-DI: 01915060000000000000603N4
Reference: M0062401000
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Glycocolle 1,5% Grifols

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratorios Grifols S.A.
Manufacturer SRN: ES-MF-000000767
UDI-DI: D-ESMF000000767725176V8
Basic UDI-DI: B-ESMF000000767725176V8
Reference: 725176
EMDN: U0380
EMDN description: DEVICES FOR URINARY TRACT DILATION - ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 20:52

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Sérum physiologique pour irrigation Grifols

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratorios Grifols S.A.
Manufacturer SRN: ES-MF-000000767
UDI-DI: D-ESMF000000767725175V6
Basic UDI-DI: B-ESMF000000767725175V6
Reference: 725175
EMDN: U0380
EMDN description: DEVICES FOR URINARY TRACT DILATION - ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 20:52

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Eau pour irrigation Grifols

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratorios Grifols S.A.
Manufacturer SRN: ES-MF-000000767
UDI-DI: D-ESMF000000767725174V4
Basic UDI-DI: B-ESMF000000767725174V4
Reference: 725174
EMDN: U0380
EMDN description: DEVICES FOR URINARY TRACT DILATION - ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 20:52

Manufacturer products View details

Glicina al 1,5% Grifols

Class IIaMDDOn the marketSingle useSterile

Manufacturer: Laboratorios Grifols S.A.
Manufacturer SRN: ES-MF-000000767
UDI-DI: D-ESMF000000767725062UQ
Basic UDI-DI: B-ESMF000000767725062UQ
Reference: 725062
EMDN: U0380
EMDN description: DEVICES FOR URINARY TRACT DILATION - ACCESSORIES
First on market country: Spain
Authorised representative: -
Last updated: 13.07.2026 20:52

Manufacturer products View details