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Butterfly iQ+ Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 850-20014Model 850-20014
Identity
- Trade Name
- Butterfly iQ+ Ultrasound System EUDAMEDBUTTERFLY iQ+ FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Butterfly iQ+ EUDAMEDFDA UDI
- Model / Reference
- 850-20014 EUDAMEDFDA UDI
- Description
- BUTTERFLY iQ+ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866646000213 EUDAMEDFDA UDI
- Basic UDI-DI
- 00866646000213KJ EUDAMED
- Direct Marketing DI
- 00866646000213 EUDAMED
- 510(k) Number
- K163510 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Butterfly iQ+ Ultrasound System by Butterfly Network, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00866646000213KJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Butterfly Network, Inc.
- EUDAMED SRN
- US-MF-000008565
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1138ab1f-a17b-4acd-b4b9-afada7c81106 61 fields · synced Jun 18, 2026
- FDA UDI af7bdee3-d2fe-4675-a521-7eb5ec878294 35 fields · synced May 30, 2026