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Rhythmia™ Mapping System M004RH12000

by Boston Scientific

Rhythmia™ Mapping System M004RH12000 is a Class II device made by Boston Scientific, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729842002), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729842002 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Rhythmia™ Mapping System
Generic name
Cardiac mapping system
Model / reference
M004RH12000
Primary DI / UDI-DI
08714729842002
FDA product code
DQK
GMDN term
Cardiac mapping system
Device class
Class II
Regulation number
870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac mapping system

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Other devices filed under Cardiac mapping system.

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Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)