← Back to catalogue
Medistim MiraQ Ultimate System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MQU02111Ref MQU02011Ref MQU14011Ref MQU04011Ref MQU14022Ref MQU14001Ref MQU12011Ref MQU04021
Identity
- Trade Name
- Medistim MiraQ Ultimate System EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDIInvasive vascular ultrasound system FDA UDI
- Device Name
- Medistim MiraQ System EUDAMED
- Model / Reference
- MQU12011 EUDAMEDFDA UDIMQU14022 EUDAMEDFDA UDIMQU14011 EUDAMEDFDA UDIMQU04011 EUDAMEDFDA UDIMQU02011 EUDAMEDFDA UDIMQU14001 EUDAMEDFDA UDIMQU02111 EUDAMEDMQU04021 EUDAMED
Identifiers
- Catalog Number
- MQU12011 FDA UDIMQU14022 FDA UDIMQU14011 FDA UDIMQU04011 FDA UDIMQU02011 FDA UDIMQU14001 FDA UDI
- Primary DI / UDI-DI
- 07070554103765 EUDAMEDFDA UDI07070554101587 EUDAMEDFDA UDI07070554103925 EUDAMEDFDA UDI07070554102973 EUDAMEDFDA UDI07070554102829 EUDAMEDFDA UDI07070554103895 EUDAMEDFDA UDI07070554101426 EUDAMED07070554103000 EUDAMED
- Basic UDI-DI
- 7070554MIRAQSYSTEMSAE EUDAMED
- Direct Marketing DI
- 07070554101426 EUDAMED07070554102829 EUDAMED07070554103925 EUDAMED07070554102973 EUDAMED07070554101587 EUDAMED07070554103895 EUDAMED07070554103765 EUDAMED07070554103000 EUDAMED
- 510(k) Number
- K102595 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIDPW FDA UDI
- EMDN Code
- Z11049099 VARIOUS ULTRASOUND INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDIInvasive vascular ultrasound system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI870.2100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiovascular ultrasound imaging system
Medistim MiraQ Ultimate System by Medi-Stim Asa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular ultrasound imaging system.
- Vivid — GE Medical Systems (China) Co., Ltd. · Class II
- iLab™ — Boston Scientific · Class II
- SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- AVVIGO™+ — Boston Scientific · Class II
- AVVIGO™+ — Boston Scientific · Class II
- Vivid — Ge Vingmed Ultrasound · Class II
Cleared under the same submission
K102595 also covers:
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medi-Stim Asa
Sources (14)
- FDA UDI 37115689-e598-46af-9c76-c1a0941856ba 34 fields · synced Sep 17, 2026
- FDA UDI b69a48dc-e06c-4d39-87de-ec1cb007b658 34 fields · synced May 25, 2026
- FDA UDI fc7857f8-b961-458e-8908-f958d9e04e13 34 fields · synced May 25, 2026
- FDA UDI 02ff5f0e-246f-4498-a0dc-8ca519c58919 34 fields · synced May 30, 2026
- FDA UDI 261d858a-f3df-4f8f-b74d-1d7a1a1f5ae9 34 fields · synced May 30, 2026
- FDA UDI eced69d9-14c1-4d18-b892-24007266726a 34 fields · synced May 30, 2026
- EUDAMED b371f9e2-fe3a-495d-8236-1ec919d8f855 61 fields · synced Jul 9, 2026
- EUDAMED 15dc0186-4e53-4512-8d1c-863c59f7f5fd 61 fields · synced Jul 16, 2026
- EUDAMED 976d84df-a830-4596-bd25-33fa8720beba 61 fields · synced Jul 18, 2026
- EUDAMED 05c65f40-e778-4e68-b971-9682d0e20f9c 61 fields · synced Jul 24, 2026
- EUDAMED 9e714dd6-d651-41f2-80cd-2294c004a2fd 61 fields · synced Jul 24, 2026
- EUDAMED 393f5a0e-bb7c-4740-9ad3-ba110e51449a 61 fields · synced Jul 28, 2026
- EUDAMED f7d1c656-00c8-4a61-96dc-cd65c3348ce1 61 fields · synced Aug 3, 2026
- EUDAMED dd4366f4-b48d-41e5-9637-f1df905aa4f8 61 fields · synced Sep 17, 2026