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

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EXALT™

Class IMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506007980
Basic UDI-DI: 01915060000000000000243MU
Reference: M0054279R0
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

EXALT™

Class IMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506007997
Basic UDI-DI: 01915060000000000000243MU
Reference: M0054279Z0
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

EXALT™

EXALT Monitor Mount

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506008024
Basic UDI-DI: 01915060000000000000244MW
Reference: M00542820
EMDN: Z12020499
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFREEZE™

SMARTFREEZE Cryo-Console Accessories

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506013523
Basic UDI-DI: 01915060000000000000299NP
Reference: M004CRBS6600
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFREEZE™

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506015701
Basic UDI-DI: 01915060000000000000299NP
Reference: M004CRBS4130
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

SMARTFREEZE™

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506015718
Basic UDI-DI: 01915060000000000000299NP
Reference: M004CRBS6340
EMDN: C020380
EMDN description: ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Point 1.5 Thermal Sensor™

Cryoablation Needles - Classic

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506017002
Basic UDI-DI: 01915060000000000000402MQ
Reference: H7493963340100
EMDN: Z120102
EMDN description: CRYOSURGERY EQUIPMENT
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Porpoise™

Porpoise Air/Water Cleaning Adapter

Class IMDR 2017/745On the marketSingle use

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506017132
Basic UDI-DI: 01915060000000000000283N8
Reference: M00501890
EMDN: G0380
EMDN description: DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

ACURATE neo2™

ACURATE neo2™ Loading Kit

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506019419
Basic UDI-DI: 01915060000000000000260MU
Reference: SYM-AC-010
EMDN: P07038002
EMDN description: CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

IntellaNav StablePoint™

STABLEPOINT CABLE (SES) 6 FT

Class IMDR 2017/745On the marketDirect markingReprocessedReusableSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506020408
Basic UDI-DI: 01915060000000000000268NC
Reference: M004RARC040
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

RHYTHMIA HDx™

Ablation Connection Box – IntellaNav StablePoint (for INTELLAGEN)

Class IMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506020798
Basic UDI-DI: 01915060000000000000452N7
Reference: M004RA63020
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Rhythmia HDx™

Ablation Connection Box (for INTELLAGEN)

Class IMDR 2017/745On the market

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506020804
Basic UDI-DI: 01915060000000000000453N9
Reference: M004RA65010
EMDN: C020199
EMDN description: CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

StoneSmart™

StoneSmart Connect Console

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506021771
Basic UDI-DI: 01915060000000000000581NK
Reference: M0067930000
EMDN: Z12020780
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

StoneSmart™

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506021795
Basic UDI-DI: 01915060000000000000581NK
Reference: M006793000D0
EMDN: Z12020780
EMDN description: GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Furlow

Furlow Disposable Insertion Tool

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506022181
Basic UDI-DI: 01915060000000000000497NV
Reference: M00635400020
EMDN: U1299
EMDN description: SINGLE-USE UROGENITAL INSTRUMENTATION (NON-ENDOSCOPIC) - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

MANTIS™

MANTIS Clip

Class IIbMDR 2017/745On the marketCMR substanceImplantableSingle useSterileSutures

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506023591
Basic UDI-DI: 01915060000000000000543NB
Reference: M00521420
EMDN: G030202
EMDN description: DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS
First on market country: Netherlands
Safety summary (SSCP/SSP): 92901964 · Rev. D
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

EcoBowl™

EcoBowl

Class IMDR 2017/745On the marketSingle use

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506027179
Basic UDI-DI: 01915060000000000000069N4
Reference: M00502694
EMDN: V0402
EMDN description: CLINICAL USE TRAYS AND BOWLS
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Acquire™

Acquire S

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506030742
Basic UDI-DI: 01915060000000000000546NH
Reference: M00555640
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Acquire™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 00191506030759
Basic UDI-DI: 01915060000000000000546NH
Reference: M00555660
EMDN: A010299
EMDN description: BIOPSY NEEDLES AND KITS - OTHER
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 08.08.2026 02:38

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: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details