EU Manufacturer
๐บ๐ธ United States
Active
Butterfly Network, Inc.
SRN: US-MF-000008565
ยท
District Avenue 1600, 01803 Burlington, United States
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
17
Basic Information
- Address
- District Avenue 1600, 01803 Burlington, United States
- [email protected]
- Website
- www.butterflynetwork.com
Regulatory Overview
Regulation
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Eu Mdr
2
Eu Mdd
1
Classification
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Eu Md Class 2a
3
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | CE 686786 | BSI Group The Netherlands B.V. | Mar 31, 2024 |
Market Presence
Devices from this manufacturer are available in 17 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Butterfly iQ Ultrasound System | EU MDD | Eu Md Class 2a | On Market | 1 |
| Butterfly iQ+ Ultrasound System | EU MDR | Eu Md Class 2a | On Market | 0 |
| Butterfly iQ3 Ultrasound System | EU MDR | Eu Md Class 2a | On Market | 0 |