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Medistim MiraQ Cardiac System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MQC12011Ref MQC04011Ref MQC02002Ref MQC14001Ref MQC02001Ref MQC04001Ref MQC02012Ref MQC12001
Identity
- Trade Name
- Medistim MiraQ Cardiac System EUDAMEDFDA UDI
- Generic Name
- Invasive vascular ultrasound system FDA UDICardiovascular ultrasound imaging system FDA UDI
- Device Name
- Medistim MiraQ System EUDAMED
- Model / Reference
- MQC02001 EUDAMEDFDA UDIMQC14001 EUDAMEDFDA UDIMQC04001 EUDAMEDFDA UDIMQC12001 EUDAMEDFDA UDIMQC12011 EUDAMEDMQC04011 EUDAMEDMQC02002 EUDAMEDMQC02012 EUDAMED
Identifiers
- Catalog Number
- MQC02001 FDA UDIMQC14001 FDA UDIMQC04001 FDA UDIMQC12001 FDA UDI
- Primary DI / UDI-DI
- 07070554101273 EUDAMEDFDA UDI07070554101495 EUDAMEDFDA UDI07070554101303 EUDAMEDFDA UDI07070554101488 EUDAMEDFDA UDI07070554103109 EUDAMED07070554102386 EUDAMED07070554102218 EUDAMED07070554102249 EUDAMED
- Basic UDI-DI
- 7070554MIRAQSYSTEMSAE EUDAMED
- Direct Marketing DI
- 07070554103109 EUDAMED07070554102386 EUDAMED07070554102218 EUDAMED07070554101495 EUDAMED07070554101273 EUDAMED07070554101303 EUDAMED07070554102249 EUDAMED07070554101488 EUDAMED
- 510(k) Number
- K102595 FDA UDI
- FDA Product Code
- DPW FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11049099 VARIOUS ULTRASOUND INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Invasive vascular ultrasound system FDA UDICardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2100 FDA UDI892.1560 FDA UDI892.1550 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: Invasive vascular ultrasound system
Medistim MiraQ Cardiac System by Medi-Stim Asa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Invasive vascular ultrasound system.
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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 Ultimate 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 |
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Manufacturer
- Manufacturer
- Medi-Stim Asa
Sources (12)
- FDA UDI 4a8a8715-6e18-4ec4-bc65-c4678fb79fbe 34 fields · synced Jul 28, 2026
- FDA UDI 6d6cbba0-6b4e-467d-a366-dbd0fa1e7510 34 fields · synced May 25, 2026
- FDA UDI c811412a-0d9d-4a1a-953d-87d43533951c 34 fields · synced May 29, 2026
- FDA UDI 26e75b46-c038-47c3-bd7d-7c7dfd81b6d9 34 fields · synced May 30, 2026
- EUDAMED 7f800a1c-b5b4-4ac8-88e7-ec95f492f843 61 fields · synced Jul 10, 2026
- EUDAMED 7f7df8cd-386a-4df4-9d1c-3957951a185b 61 fields · synced Jul 10, 2026
- EUDAMED f57d4e0f-078a-4c37-a68d-77150f625085 61 fields · synced Jul 12, 2026
- EUDAMED 8dc58351-d71e-4332-ac19-3bdc73b348ec 61 fields · synced Jul 14, 2026
- EUDAMED 5b1a4d4b-b77c-4fcf-a7c9-0d75a9ab5471 61 fields · synced Jul 16, 2026
- EUDAMED 5f10a128-e315-45c6-a106-d016895b577d 61 fields · synced Jul 17, 2026
- EUDAMED 89b78141-0bf0-425c-8406-66c27ca34962 61 fields · synced Jul 18, 2026
- EUDAMED de8b4099-41f2-4caa-8cb3-9cd3bf73cffe 61 fields · synced Jul 28, 2026