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Medistim MiraQ Vascular System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MQV14021Ref MQV04021Ref MQV14011Ref MQV04001Ref MQV14010Ref MQV14001Ref MQV02110Ref MQV12022Ref MQV04121Ref MQV14022
Identity
- Trade Name
- Medistim MiraQ Vascular System EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDIInvasive vascular ultrasound system FDA UDI
- Device Name
- Medistim MiraQ System EUDAMED
- Model / Reference
- MQV14010 EUDAMEDFDA UDIMQV14011 EUDAMEDFDA UDIMQV14022 EUDAMEDFDA UDIMQV14001 EUDAMEDFDA UDIMQV04001 EUDAMEDFDA UDIMQV14021 EUDAMEDMQV04021 EUDAMEDMQV02110 EUDAMEDMQV12022 EUDAMEDMQV04121 EUDAMED
Identifiers
- Catalog Number
- MQV14010 FDA UDIMQV14011 FDA UDIMQV14022 FDA UDIMQV14001 FDA UDIMQV04001 FDA UDI
- Primary DI / UDI-DI
- 07070554103604 EUDAMEDFDA UDI07070554103611 EUDAMEDFDA UDI07070554101549 EUDAMEDFDA UDI07070554103581 EUDAMEDFDA UDI07070554102676 EUDAMEDFDA UDI07070554101532 EUDAMED07070554102720 EUDAMED07070554101341 EUDAMED07070554103475 EUDAMED07070554101389 EUDAMED
- Basic UDI-DI
- 7070554MIRAQSYSTEMSAE EUDAMED
- Direct Marketing DI
- 07070554101532 EUDAMED07070554102720 EUDAMED07070554103611 EUDAMED07070554102676 EUDAMED07070554103604 EUDAMED07070554103581 EUDAMED07070554101341 EUDAMED07070554103475 EUDAMED07070554101389 EUDAMED07070554101549 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 UDIFDA 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 Vascular 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 Ultimate 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 (15)
- FDA UDI 52a77dc7-daf3-42b0-b634-014b5f76e717 34 fields · synced Jul 30, 2026
- FDA UDI b79e65ed-f6d9-43d7-88b3-a014ee66f248 34 fields · synced May 27, 2026
- FDA UDI b44ed5a0-9c03-453f-9f39-889cce9d9a9b 34 fields · synced May 30, 2026
- FDA UDI 98ca2241-c281-4f8f-a906-20e83d888b32 34 fields · synced May 30, 2026
- FDA UDI 509e5471-ca53-4c60-9a00-9e825567dd97 34 fields · synced May 30, 2026
- EUDAMED 25429087-d0b2-4492-b131-a3d1a5261f09 61 fields · synced Jul 8, 2026
- EUDAMED 39837ffa-6fec-4e12-a8cc-1ff81cd1b5f2 61 fields · synced Jul 9, 2026
- EUDAMED 8743e683-2778-4884-bb76-09ff5c860192 61 fields · synced Jul 12, 2026
- EUDAMED b5dbf1af-c00a-4332-9489-fb61d02b7d6f 61 fields · synced Jul 13, 2026
- EUDAMED 8215adb2-9f56-44ec-86a9-235c51fc157e 61 fields · synced Jul 16, 2026
- EUDAMED adef0d2e-432e-485e-86f1-1eb7a290d560 61 fields · synced Jul 25, 2026
- EUDAMED cad050a3-0698-4713-8180-6d05bad5154f 61 fields · synced Jul 26, 2026
- EUDAMED be7439f2-d59f-4494-9f1a-90a7d4fcf116 61 fields · synced Jul 30, 2026
- EUDAMED 38acfc3b-6db5-48db-b1db-b633cac44cf3 61 fields · synced Jul 30, 2026
- EUDAMED 314b0178-5571-4b42-b20d-56569102e396 61 fields · synced Jul 30, 2026