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Butterfly iQ+ Bladder Ultrasound System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 850-20028-XX
Identity
- Trade Name
- Butterfly iQ+ Bladder Ultrasound System EUDAMEDFDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Butterfly iQ+ Bladder Ultrasound System EUDAMED
- Model / Reference
- 850-20028-XX EUDAMED850-20028 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027593081 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850027593081E6 EUDAMED
- Direct Marketing DI
- 00850027593081 EUDAMED
- FDA Product Code
- ITX FDA UDIIYO 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
- 892.1570 FDA UDI892.1560 FDA UDI
- 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
MR Unsafe FDA UDI
Butterfly iQ+ Bladder 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 | 00850027593081E6 | 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 bac76d13-5974-4ee8-b58b-e08a7a0f383c 61 fields · synced Oct 6, 2026
- FDA UDI 8c02bad2-e094-46b0-9d1f-33924d9768b7 32 fields · synced May 30, 2026