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MICROPACE PTY LIMITED OneStim

by Micropace Pty Limited

Ref MP5000-4ST, MP5001-2PA, MP5002-4MI, MP5003-4CO

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09349714010877 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number93497140MP3485KR Basic UDI-DI 09349714010877UDI-DIDate7 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
OneStim EUDAMED
Micropace Pty Limited GUDID
Generic Name
Cardiac electrophysiology stimulation system
Device Name
Micropace EPS320 Configurable Cardiac Stimulator System
Model / Ref / Catalog
MP5000-4ST, MP5001-2PA, MP5002-4MI, MP5003-4CO, OneStim
Primary DI / UDI-DI
09349714010877
Basic UDI-DI
93497140MP3485KR
510(k) Number
FDA Product Code
JOQ, DQK
EMDN Code
Z12050699 Non–implantable cardiac stimulators – other
GMDN Term
Cardiac electrophysiology stimulation system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1750, 870.1425
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MP5000-4ST, MP5001-2PA, MP5002-4MI, MP5003-4CO
GUDID
OneStim
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Micropace Pty Limited

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No