Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAbatement Technologies, Inc.
US
Last updated May 30, 2026
What Abatement Technologies, Inc. makes
Abatement Technologies, Inc. manufactures mobile and stationary high-efficiency filter air cleaners, including HEPA-filtered units, and ultraviolet ambient disinfection lights designed for air purification and pathogen reduction.
The company’s products are regulated as Class II medical devices in the US, with authorisations recorded via FDA 510(k) and FDA UDI registries. The manufacturer 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 types of medical devices does Abatement Technologies, Inc. manufacture?
Abatement Technologies, Inc. specializes in air purification solutions, producing mobile and stationary high-efficiency filter air cleaners (often featuring HEPA filters) and ultraviolet ambient disinfection lights. These devices are designed to improve indoor air quality and reduce pathogens, such as airborne bacteria or viruses, in various environments.
Where is Abatement Technologies, Inc. based, and how does that affect its regulatory oversight?
Abatement Technologies, Inc. is based in the United States. As a US-based manufacturer, its devices fall under FDA jurisdiction, where they are classified as Class II medical devices. This classification requires pre-market authorisation via pathways like the FDA 510(k) process, ensuring compliance with safety and performance standards before commercialisation.
Which regulatory registries list Abatement Technologies, Inc.’s devices, and why?
Abatement Technologies, Inc.’s devices are listed in the FDA 510(k) and FDA Unique Device Identification (UDI) registries. The 510(k) process confirms that new devices are substantially equivalent to legally marketed predecessors, while UDI registration ensures traceability and transparency in the supply chain. Both registries are critical for tracking authorised devices and maintaining compliance with US medical device regulations.
How are Abatement Technologies, Inc.’s devices classified under US regulations, and what does that mean?
Abatement Technologies, Inc.’s devices are classified as Class II under FDA regulations. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. While not as stringent as Class III (high-risk) devices, Class II devices still undergo pre-market review—such as the 510(k) pathway—to validate their performance and compliance with applicable standards before they can be marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- abatement.com
- —
- —
- [email protected]
- Phone
- 18006349091
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 173503806
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hepa-Care® | HC500CD | FDA UDI | Class II | Active |
| Hepa-Care® | HC400FDUV | FDA UDI | Class II | Active |
| Hepa-Care® | UV800F | FDA UDI | Class II | Active |
| Hepa-Care® | HC600FUVTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC400CD | FDA UDI | Class II | Active |
| Hepa-Care® | UV400C-PT | FDA UDI | Class II | Active |
| Hepa-Care® | HC600FTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC800F | FDA UDI | Class II | Active |
| Hepa-Care® | HC800FTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC600FTF-G | FDA UDI | Class II | Active |
| Hepa-Care® | HC800FD | FDA UDI | Class II | Active |
| Hepa-Care® | HC400FUV | FDA UDI | Class II | Active |
| Hepa-Care® | HC600F | FDA UDI | Class II | Active |
| Hepa-Care® | UV400C | FDA UDI | Class II | Active |
| Hepa-Care® | HC400FD | FDA UDI | Class II | Active |
| Hepa-Care® | HC500FD | FDA UDI | Class II | Active |
| Hepa-Care® | HC800FDUV | FDA UDI | Class II | Active |
| Hepa-Care® | HC800C | FDA UDI | Class II | Active |
| Hepa-Care® | HC800CTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC600FTS-G | FDA UDI | Class II | Active |
| Hepa-Care® | HC500FDUV | FDA UDI | Class II | Active |
| Hepa-Care® | HC400F | FDA UDI | Class II | Active |
| Hepa-Care® | HC800FTFULPA-G | FDA UDI | Class II | Active |
| Hepa-Care® | HC800FDTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC800CD | FDA UDI | Class II | Active |
| Hepa-Care® | HC400FUVTF | FDA UDI | Class II | Active |
| Hepa-Care® | HC600FUV | FDA UDI | Class II | Active |
| Hepa-Care Air Cleaner American Air Filter Air Filtration System Models Hc800f, Hfs800f, Hc800c/ Hfs800c, Hc400c/Hfs400c | K984116 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Abatement Technologies Limited FORT ERIE Ontario · CA FEI 3000135138