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Medistim MiraQ Cardiac System MQC12001

by Medi-Stim Asa

Ref MQC12001

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7070554MIRAQSYSTEMSAE Basic UDI-DI 07070554101488UDI-DIDate7 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07070554101488 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-0410-2026 FDA Class II initiated 26 Sep 2025

    Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

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  • Withdrawn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
Medistim MiraQ Cardiac System
Generic Name
Cardiovascular ultrasound imaging system
Device Name
Medistim MiraQ System
Model / Ref / Catalog
MQC12001
Primary DI / UDI-DI
07070554101488
Basic UDI-DI
7070554MIRAQSYSTEMSAE
Direct Marketing DI
07070554101488
510(k) Number
FDA Product Code
DPW, IYO, IYN
EMDN Code
Z11049099 Various ultrasound instruments - other
GMDN Term
Cardiovascular ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2100, 892.1560, 892.1550
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K102595)

Show all (12)

Other devices from Medi-Stim Asa

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Measuring Function: 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