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BUTTERFLY NETWORK, INC.

USA · Burlington

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 5 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

1active device licences

Class III 1

3 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: BUTTERFLY NETWORK, INC. · BUTTERFLY NETWORK INC.

Business registration

CIK: 0001804176
Registration status: Active
Listing status: Listed (BFLY)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12017 · K163510

22020 · K202406

12023 · K220068

12024 · K232808

12026 · K252148

FDA listed device types

Automated Radiological Image Processing Software 1System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252148	Butterfly Gestational Age Tool	2026-03-27
US	K232808	Butterfly iQ3 Ultrasound System	2024-01-04
US	K220068	Butterfly iQ/iQ+ Ultrasound System	2023-03-31
BR	80117589168	Butterfly Ultrasound System	Class II
CA	104476	BUTTERFLY IQ ULTRASOUND SYSTEM	Class III

BUTTERFLY NETWORK, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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