Is this your brand? Sign in to claim ownership.
Sign in to claim this brandExergen Corporation
United States·US-MF-000011488
Last updated September 17, 2026
About
For over 25 years, Harvard research scientist, Dr. Francesco Pompei and wife Dr. Marybeth Pompei have been using non-invasive technologies to create innovative medical tools that work better for patients. This dedication to customer-focused innovation has cemented Exergen’s reputation as a reliable provider of high-quality, precise temperature measurement solutions.
From the manufacturer's own website. Source
What Exergen Corporation makes
Exergen Corporation manufactures infrared thermometers designed for non-invasive temperature measurement, including devices that scan the temporal artery region of the forehead and ear-based models. The company produces handheld and portable units, such as the Exergen Temporal Scanner and Exergen DermaTemp, intended for clinical and home use to assess body temperature quickly and accurately.
The company’s devices fall under FDA Class II and Class IIa classifications, with some listed in the EU’s eudamed registry and authorised via FDA 510(k) clearances and UDI submissions. These products are regulated under medical device standards applicable to thermometers, ensuring compliance with safety and performance requirements. 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 Exergen Corporation manufacture?
Exergen Corporation specializes in infrared thermometers designed for non-invasive temperature measurement. Their primary products include devices that scan the temporal artery region of the forehead (such as the Exergen Temporal Scanner) and ear-based models. These handheld and portable units are intended for both clinical and home use to provide quick and accurate body temperature readings.
Where is Exergen Corporation based?
Exergen Corporation is headquartered in the United States. The company’s location influences its regulatory compliance, as its devices are authorised under U.S. FDA standards and may also appear in international registries like eudamed for EU market access.
Which regulatory registries list Exergen’s devices?
Exergen’s devices are listed in the EU’s eudamed registry, which tracks medical devices authorised for sale in the European Economic Area. Additionally, their products are authorised via FDA 510(k) clearances and UDI (Unique Device Identification) submissions in the U.S., ensuring traceability and compliance with both regional regulatory frameworks.
How are Exergen’s devices classified under medical device regulations?
Exergen’s devices fall under FDA Class II and Class IIa classifications. Class II devices typically require special controls to ensure their safety and effectiveness, while Class IIa (a subset of Class II) may involve additional regulatory oversight due to moderate risk. These classifications align with the FDA’s categorisation of thermometers, which are considered essential for patient monitoring but require validation for accuracy and reliability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 400, Pleasant Street, Watertown, United States
- Website
- www.exergen.com
- facebook.com/Exergen.Corporation
- [email protected]
- Phone
- 6179239900
- PRRC Contact
- Tanya Porter
- EUDAMED SRN
- US-MF-000011488
- FDA FEI Number
- 1221195
- DUNS Number
- —
Catalogue (74)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Exergen Temporal Scanner | TAT5000S-USB | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C Smart Glow | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C Smart Glow | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-TTL | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C Smart Glow | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-USB | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 | FDA UDI | Class II | Active |
| Exergen Light Touch | LXN-1 | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT5000 Quick Release | FDA UDI | Class II | Active |
| Exergen DermaTemp | Dermatemp 1001 | FDA UDI | Class II | Active |
| Exergen Light Touch | LXTA | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT5000S-CORO | FDA UDI | Class II | Active |
| Exergen Light Touch | LTX-1 | FDA UDI | Class II | Unknown |
| Exergen Light Touch | LTX-1 | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT2000C Original | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT5000S-TTL | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-USB | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 Dual Security | FDA UDI | Class II | Active |
| Exergen Light Touch | LTX-1 | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT5000 Quick Release | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-TTL | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 | FDA UDI | Class II | Active |
| Exergen DermaTemp | DT-2000 BT | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C | FDA UDI | Class II | Active |
| Exergen DermaTemp | Dermatemp 1001 | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-USB | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-USB | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S-232EP | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 Dual Security | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 | FDA UDI | N/A | Active |
| Exergen Temporal Scanner | TAT5000 Dual Security | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S | FDA UDI | N/A | Active |
| Exergen Light Touch | LTX-1 | FDA UDI | Class II | Unknown |
| Exergen Thermographic Scanner | DT-5000S-USB | FDA UDI | Class II | Active |
| Exergen DermaTemp | Dermatemp 1001 | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 | FDA UDI | Class II | Active |
| Oto Temp Probe Covers | PCT-2500 Disposable Wraps | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-CORO | FDA UDI | Class II | Active |
| Disposable Caps | 134203 | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT-5000S | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT2000C | FDA UDI | Class II | Unknown |
| Exergen Temporal Scanner | TAT5000S-RS232-MR | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-RS232-QR | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000 Dual Security | FDA UDI | Class II | Active |
| Exergen Temporal Scanner | TAT5000S-TTL | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.