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Rhythmia™ Mapping System M004RAPATCH10

by Boston Scientific

Ref M004RAPATCH10

Rhythmia™ Mapping System M004RAPATCH10 is a device classified as Class I in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 01915060000000000000215MP) and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 08714729841890), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000215MP Basic UDI-DI 08714729841890UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729841890 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000215MP registered 24 Oct 2025 Active
  • FDA GUDID UDI-DI 08714729841890 listed 14 Mar 2017 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 08714729841890
  2. Registered EUDAMED 01915060000000000000215MP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Rhythmia™ EUDAMED
Rhythmia™ Mapping System GUDID
Generic name
Cardiac mapping system reference patch
Device name
Rhythmia HDx Patch Kit
Model / reference
M004RAPATCH10
Primary DI / UDI-DI
08714729841890
Basic UDI-DI
01915060000000000000215MP
FDA product code
DQK
EMDN code
C020199 Cardiac electrophysiology and mapping devices - other
GMDN term
Cardiac mapping system reference patch
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiac mapping system reference patch

Similar devices in this category

Other devices filed under CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)