Who else makes this device?

Name: Medistim MiraQ Cardiac System
Brand: Medistim MiraQ Cardiac System

Cardiovascular › MonitoringFlowmeter, Blood, Cardiovascular

Medistim MiraQ Cardiac System

6 catalogue numbers from MQC02001, listed by Medistim ASA, Norway, under Flowmeter, Blood, Cardiovascular. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

6catalogue numbers in this listing

2recalls on this code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code DPW
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Helen of Troy Macao Limited	Macau	Guangdong	Private-label distributor	11
Dongguan Mars Medical Products Co., Ltd.	Dongguan	Guangdong	Manufacturer	9
Onbo Electronic (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6

Record

Regulatory record for Medistim MiraQ Cardiac System
Listed by	Medistim ASA, Norway
FDA product code	DPW
Device type	Flowmeter, Blood, Cardiovascular
Device class	Class 2
Regulation	21 CFR 870.2100
Establishment	Specification developer, Manufacturer
510(k)	K102595
Record published	2016-09-15
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Medistim MiraQ Cardiac System
Catalogue number	Size	Status
MQC02001		In distribution
MQC04001		In distribution
MQC14002		In distribution
MQC14001		In distribution
MQC12001		In distribution
MQC04102		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Transonic	Transonic Systems, Inc.	627
SonoTT Vascular Probe	Em-Tec GmbH	12
BiDop 7 probe	Koven Technology, Inc.	8
Medistim MiraQ Vascular System	Medistim ASA	6
FlowMet™	Medtronic, Inc.	4
GEM Flow Coupler	Synovis Micro Companies Alliance	4
CooperSurgical®	Coopersurgical, Inc.	4
Medistim System Activation Card	Medistim ASA	3
811-BL 24V Foreign & Domestic	Parks Medical Electronics, Inc.	3
Medistim MiraQ Ultimate System	Medistim ASA	3
Dopplex	Huntleigh Healthcare Ltd.	3
VascuChek Transceiver	Remington Medical, Inc.	2

Showing 12 of 154. All products under Flowmeter, Blood, Cardiovascular

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Medistim MiraQ Cardiac System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Medistim ASA	510(k) number	2025-09-26	Class II	Process control	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.	14

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2017-04-25	Class II	Nonconforming Material/Component	A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.	2	2024-05-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.