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

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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

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08714729005209

UROLOGY INTRODUCERS

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729005209
Basic UDI-DI: 01915060000000000000602N2
Reference: M0067001200
EMDN: U040299
EMDN description: DEVICES FOR PERCUTANEOUS NEPHROSTOMY - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:07

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08714729005162

C-Flex Ureteral Catheter

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729005162
Basic UDI-DI: 01915060000000000000562NF
Reference: M0064001500
EMDN: U020101
EMDN description: URETERAL CATHETERS WITH CYLINDRICAL TIP
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:07

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RescueNet™

RescueNet Retrieval Device

Class IMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00840253107428
Basic UDI-DI: 01915060000000000000622N8
Reference: DGN-538
EMDN: G0305010202
EMDN description: DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, NON-REVOLVING
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:07

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OPAL HDx™

OPAL HDx LOCATION REFERENCE PATCH KIT G2

Class IMDR 2017/745On the marketSingle use

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506064990
Basic UDI-DI: 01915060000000000000678P3
Reference: M004OPALPATCH20
EMDN: C020180
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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Eso-SPONGE™

Eso-SPONGE

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506058920
Basic UDI-DI: 01915060000000000000638NP
Reference: M00514510
EMDN: A0699
EMDN description: DRAINAGE AND FLUID COLLECTION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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Endo-SPONGE™

Endo-SPONGE

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506058890
Basic UDI-DI: 01915060000000000000637NM
Reference: M00514500
EMDN: A0699
EMDN description: DRAINAGE AND FLUID COLLECTION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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OPAL HDx™

OPAL HDx™ Mapping System

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506056476
Basic UDI-DI: 01915060000000000000598P4
Reference: M004OPALINSTLLROW0
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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OPAL HDx™

OPAL HDx™ Mapping System Signal Station

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506055325
Basic UDI-DI: 01915060000000000000599P6
Reference: M004OPAL10200
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

OPAL HDx™

OPAL HDx™ Mapping System Workstation PC

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506055301
Basic UDI-DI: 01915060000000000000600MW
Reference: M004OPAL40100
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR™

FARASTAR Cable Set

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506052447
Basic UDI-DI: 01915060000000000000621N6
Reference: M004PF61M499D
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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LithoVue™

LithoVue Elite Single-Use Digital Flexible Ureteroscope

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506050634
Basic UDI-DI: 01915060000000000000579NY
Reference: M0067941010
EMDN: Z12020709
EMDN description: UTEROSCOPES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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rezūm™

Rezum EVO Console

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506047337
Basic UDI-DI: 01915060000000000000625NE
Reference: M006RZG21000
EMDN: Z12160302
EMDN description: EQUIPMENT FOR LIQUID PROSTATE THERMOTHERAPY
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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OverStitch™

OverStitch ESS

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506049089
Basic UDI-DI: 01915060000000000000587NX
Reference: M00505400
EMDN: G030899
EMDN description: INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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FARAPULSE PFA Capital Equipment

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506042547
Basic UDI-DI: 01915060000000000000536NE
Reference: M004PFCE61M401
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR™

FARAPULSE PFA Capital Equipment Components

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506042462
Basic UDI-DI: 01915060000000000000537NG
Reference: M004PF61M409
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

FARASTAR™

FARASTAR Catheter Connection Cables

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506041649
Basic UDI-DI: 01915060000000000000670NK
Reference: M004PF41M424
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

Dreamtome™

Sphincterotome

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506039240
Basic UDI-DI: 01915060000000000000521MZ
Reference: M00584400
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

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Autotome™

Cannulating Sphincterotome

Class IIbMDR 2017/745On the marketActive deviceCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506039226
Basic UDI-DI: 01915060000000000000520MX
Reference: M00584380
EMDN: G03040202
EMDN description: PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details

ACURATE Prime™

ACURATE Prime Loading Kit

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506030971
Basic UDI-DI: 01915060000000000000567NR
Reference: H749396942325
EMDN: P07038002
EMDN description: CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:02

Manufacturer products Authorised representative products Authorised representative actors View details