EU Manufacturer
🇺🇸 United States
Active
Hyperfine, Inc.
SRN: US-MF-000029806
·
351 New Whitfield Street, 06437 Guilford, CT, United States
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
9
Basic Information
- Address
- 351 New Whitfield Street, 06437 Guilford, CT, United States
- [email protected]
- Website
- www.hyperfine.io
Regulatory Overview
Regulation
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Eu Mdr
5
Classification
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Eu Md Class 1
4
Eu Md Class 2a
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 9 countries across Europe.
🇩🇪 Germany
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇳🇴 Norway
🇵🇱 Poland
🇷🇴 Romania
🇸🇪 Sweden
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER | EU MDR | Eu Md Class 1 | On Market | 0 |
| PATIENT POSITIONING MEDICAL CUSHIONS | EU MDR | Eu Md Class 1 | On Market | 0 |
| PATIENT POSITIONING MEDICAL CUSHIONS | EU MDR | Eu Md Class 1 | On Market | 0 |
| PATIENT POSITIONING MEDICAL CUSHIONS | EU MDR | Eu Md Class 1 | On Market | 0 |
| Swoop® Portable MR Imaging® System | EU MDR | Eu Md Class 2a | On Market | 0 |