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EUDAMED Device Search

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

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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: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

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: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

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: 08.08.2026 02:38

Manufacturer products Authorised representative products Authorised representative actors View details

Stone Cone™

Stone Cone Nitinol Urological Retrieval Coil

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729430223
Basic UDI-DI: 01915060000000000000585NT
Reference: M0063903200
EMDN: U090199
EMDN description: URINARY STONE RETRIEVAL DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 07.08.2026 08:06

Manufacturer products Authorised representative products Authorised representative actors View details

Stone Cone™

Stone Cone Nitinol Urological Retrieval Coil

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729430209
Basic UDI-DI: 01915060000000000000585NT
Reference: M0063903100
EMDN: U090199
EMDN description: URINARY STONE RETRIEVAL DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 07.08.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

IntellaTip MiFi™

IntellaTip MiFi Filter Module

Class IMDR 2017/745On the marketReprocessed

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729847939
Basic UDI-DI: 01915060000000000000207MQ
Reference: M00412120
EMDN: C020399
EMDN description: CARDIAC TISSUE ABLATION DEVICES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 06.08.2026 01:46

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Coyote™ ES Monorail™ and Over-The-Wire PTA Balloon Dilatation Catheters

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767169
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135152010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 05.08.2026 15:43

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767190
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135204010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767220
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135254010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767206
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135252010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767282
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135354010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767183
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135203010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767244
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135303010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767237
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135302010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767251
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135304010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767275
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135353010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767268
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135352010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767213
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135253010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767305
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135403010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Coyote™

Class IIaMDR 2017/745On the marketCMR substanceSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729767176
Basic UDI-DI: 01915060000000000000494NP
Reference: H74939135202010
EMDN: C010402020101
EMDN description: PTA BALLOON DILATATION CATHETERS
First on market country: -
Authorised representative: Boston Scientific Limited
Last updated: 04.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details