EU Manufacturer
๐บ๐ธ United States
Active
Infraredx, Inc.
SRN: US-MF-000002341
ยท
28 Crosby Drive, 01730 Bedford, Massachusetts, United States
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
16
Basic Information
- Address
- 28 Crosby Drive, 01730 Bedford, Massachusetts, United States
- [email protected]
- Phone
- +1 888-680-7339
- Website
- https://www.infraredx.com/
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 2a
1
Eu Md Class 3
1
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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Market Presence
Devices from this manufacturer are available in 16 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ธ๐ช Sweden
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Dualproโข IVUS+NIRS Imaging Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| Makoto Intravascular Imaging Systemโข | EU MDD | Eu Md Class 2a | On Market | 1 |