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Sign in to claim this brandAffera, Inc.
United States·US-MF-000018093
Last updated September 18, 2026
About
Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing cardiac arrhythmia market.
From the manufacturer's own website. Source
What Affera, Inc. makes
Affera, Inc. manufactures medical devices including the HexaFLOW Tubing Set, Prism-1 Mapping System, and Catheter Extension Cable, which are used in cardiac procedures.
The company's products are classified as Class I and Class IIa medical devices and are listed in the EUDAMED regulatory registry. Affera is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What medical devices does Affera, Inc. manufacture?
Affera, Inc. manufactures medical devices including the HexaFLOW Tubing Set, Prism-1 Mapping System, and Catheter Extension Cable, which are used in cardiac procedures to address cardiac arrhythmia conditions.
Where is Affera, Inc. based?
Affera, Inc. is based in the United States, where the company develops and produces its medical devices for the cardiac arrhythmia market.
Which regulatory registries list Affera's devices?
Affera's medical devices are listed in the EUDAMED regulatory registry, which is the European database on medical devices, ensuring their compliance with regulatory requirements.
How are Affera's medical devices classified?
Affera's medical devices are classified as Class I and Class IIa, with Class I being low-risk devices and Class IIa being moderate-risk devices requiring more stringent controls for safety and performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 320, Nevada Street, Newton, United States
- Website
- affera.com
- —
- [email protected]
- Phone
- +1 857 304 4030
- PRRC Contact
- John Brandstetter
- EUDAMED SRN
- US-MF-000018093
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HexaFLOW Tubing Set | AFR-00002 | EUDAMED | Class IIa | Active |
| Prism-1 Mapping System | AFR-00003 | EUDAMED | Class IIa | Active |
| Catheter Extension Cable | AFR-00006 | EUDAMED | Class I | Active |
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