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Praveza ® Ureteral Access Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Blue Neem Medical Devices Private Limited
Manufacturer SRN: IN-MF-000021793
UDI-DI: 08905080008446
Basic UDI-DI: 8905080BUAGS
Reference: BUAB01203500
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: -
Authorised representative: Arazy Group (Ireland) Ltd.
Last updated: 03.07.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Praveza ® Ureteral Access Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Blue Neem Medical Devices Private Limited
Manufacturer SRN: IN-MF-000021793
UDI-DI: 08905080008453
Basic UDI-DI: 8905080BUAGS
Reference: BUAB01204500
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: -
Authorised representative: Arazy Group (Ireland) Ltd.
Last updated: 03.07.2026 12:34

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Praveza ® Ureteral Access Sheath

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Blue Neem Medical Devices Private Limited
Manufacturer SRN: IN-MF-000021793
UDI-DI: 08905080008460
Basic UDI-DI: 8905080BUAGS
Reference: BUAB01205500
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: -
Authorised representative: Arazy Group (Ireland) Ltd.
Last updated: 03.07.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

08015262036249

Applicatore uretrale

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: PENTAFERTE ITALIA SRL
Manufacturer SRN: IT-MF-000040982
UDI-DI: 08015262036249
Basic UDI-DI: 80152621114R
Reference: 02452101
EMDN: U03010201
EMDN description: URETHRAL DILATORS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:22

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06976132631709

DYQ-B

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Hangzhou Hawk Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000040170
UDI-DI: 06976132631709
Basic UDI-DI: 697613263DYQ003KL
Reference: P10040202
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Türkiye
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 20:45

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Beyomed

BY-UB

Class IIaMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Suzhou Beyo Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000005660
UDI-DI: 06972567829124
Basic UDI-DI: 697256782SNGQN001PB
Reference: BY-UB-0506
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:59

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06972567822279

BY-AS

Class IIaMDR 2017/745Not intended for EU marketSingle useSterile

Manufacturer: Suzhou Beyo Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000005660
UDI-DI: 06972567822279
Basic UDI-DI: 697256782DYQ001RP
Reference: BY-AS-1025
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:59

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Single-use Ureteral Access Sheath

UA-S1800、UA-S1801、UA-S1A00、UA-S1A01、UA-S1B00、UA-S1B01、UA-S1C00、UA-S1C01、UA-S1D00、UA-S1D01

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000002593
UDI-DI: 06972197482225
Basic UDI-DI: 697219748UA01ND
Reference: UA-S1800
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

BM Ureteral Dilation Balloon Catheters

4x40 4x60 4x100 5x40 5x60 5x100 6x40 6x60 6x100 7x40 7x60 7x100 8x40 8x60 8x100 10x40 10x60 10x100

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Bonree Medical Co., Ltd.
Manufacturer SRN: CN-MF-000017844
UDI-DI: 06972091927006
Basic UDI-DI: 697209192UDBC40KD
Reference: 406 04 12 2
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:32

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BM Ureteral Dilators

6FR, 8FR, 9FR, 10FR, 11FR,12FR, 14FR, 16FR, 18FR

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Bonree Medical Co., Ltd.
Manufacturer SRN: CN-MF-000017844
UDI-DI: 06972091926733
Basic UDI-DI: 697209192UED38KF
Reference: 405 06 22 2
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 12:32

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06971176281637

PUS-100-1040, PUS-100-1050, PUS-100-1240, PUS-100-1250

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000009220
UDI-DI: 06971176281637
Basic UDI-DI: 697117628NE8
Reference: PUS-100-1040 (English labelling)
EMDN: U0380
EMDN description: DEVICES FOR URINARY TRACT DILATION - ACCESSORIES
First on market country: Cyprus
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:39

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Balloon Ureteral Dilator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000012832
UDI-DI: 06942127890079
Basic UDI-DI: 697067138BU054EP
Reference: AF-DUB0710BF
EMDN: U030201
EMDN description: URETHRAL DILATORS, WITH BALLOON
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:27

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Ureteral Access Sheathes

Class IIaMDR 2017/745On the market

Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000008462
UDI-DI: 06941513220971
Basic UDI-DI: 697005757111HE
Reference: VDK-NSA-14550A-1
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

Ureteral Access Sheathes

Class IIaMDR 2017/745On the market

Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000008462
UDI-DI: 06941513202991
Basic UDI-DI: 697005757110HC
Reference: VDK-USA-12420A
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

Renal Dilator Set

ZSR-RD01、ZSR-RD02、ZSR-RD03、ZSR-RD06

Class IIaMDR 2017/745On the market

Manufacturer: Dongguan ZSR Biomedical Technology Company Limited
Manufacturer SRN: CN-MF-000016828
UDI-DI: 06936345101765
Basic UDI-DI: 69363451ZSRRDS01194
Reference: ZSR-RD01-12
EMDN: U03010199
EMDN description: PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER
First on market country: Poland
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable Ureteral Guide Sheath

ZSR-UA, ZSR-UAY, ZSR-UAW

Class IIaMDR 2017/745On the market

Manufacturer: Dongguan ZSR Biomedical Technology Company Limited
Manufacturer SRN: CN-MF-000016828
UDI-DI: 06936345101536
Basic UDI-DI: 69363451ZSRUGS007BM
Reference: ZSR-UA-1135
EMDN: U03010202
EMDN description: URETERAL DILATORS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 10:05

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Prospect® Ureteral Dilatation Balloon Catheter

090400400851-1

Class IMDR 2017/745On the market

Manufacturer: Princeton Medical Scientific Co.,Ltd
Manufacturer SRN: CN-MF-000018402
UDI-DI: 06935456208776
Basic UDI-DI: 69354562PLYL09XT
Reference: 090400400851-1
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Türkiye
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tahina 0.038" Nephrostomy Balloon Dilator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ENVASTE LTD
Manufacturer SRN: MU-MF-000030801
UDI-DI: 60913190405468
Basic UDI-DI: 60913190UDB-039G
Reference: UDB-0308120S
EMDN: U0399
EMDN description: DEVICES FOR URINARY TRACT DILATION - OTHER
First on market country: Ireland
Authorised representative: ENVASTE LTD
Last updated: 02.07.2026 07:56

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Tahina 0.018" Ureteroscopy Balloon Dilator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ENVASTE LTD
Manufacturer SRN: MU-MF-000030801
UDI-DI: 60913190405222
Basic UDI-DI: 60913190UDB-029E
Reference: UDB-0204040S
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Ireland
Authorised representative: ENVASTE LTD
Last updated: 02.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Tahina 0.038" Ureteral Balloon Dilator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: ENVASTE LTD
Manufacturer SRN: MU-MF-000030801
UDI-DI: 60913190404164
Basic UDI-DI: 60913190UDB-019C
Reference: UDB-0104040S
EMDN: U030202
EMDN description: URETERAL DILATORS, WITH BALLOON
First on market country: Ireland
Authorised representative: ENVASTE LTD
Last updated: 02.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details