EU Manufacturer
๐บ๐ธ United States
Active
Affera, Inc.
SRN: US-MF-000018093
ยท
Nevada Street 320, 02460 Newton, United States
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Nevada Street 320, 02460 Newton, United States
- [email protected]
- Phone
- +1 857 304 4030
- Website
- affera.com
Regulatory Overview
Regulation
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Eu Mdr
5
Classification
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Eu Md Class 1
3
Eu Md Class 2a
2
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES | EU MDR | Eu Md Class 1 | On Market | 0 |
| CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES | EU MDR | Eu Md Class 1 | On Market | 0 |
| CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES | EU MDR | Eu Md Class 1 | On Market | 0 |
| HexaFLOW Tubing Set | EU MDR | Eu Md Class 2a | On Market | 0 |
| Prism-1 Mapping System | EU MDR | Eu Md Class 2a | On Market | 0 |