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Sign in to claim this brandBroder Bros., Co.
US
Last updated May 27, 2026
What Broder Bros., Co. makes
Broder Bros., Co. manufactures intermittent electronic patient thermometers, including digital models designed for clinical and home use. Their portfolio includes devices such as the PC600 Digital Thermometer in a white finish, as well as generic digital thermometers for temperature monitoring.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device compliance requirements.
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 Broder Bros., Co. manufacture?
Broder Bros., Co. specializes in intermittent electronic patient thermometers, primarily digital models. These devices are designed for both clinical and home use, enabling accurate temperature monitoring for patients. The focus is on simplicity and reliability for measuring body temperature.
Where is Broder Bros., Co. based, and does that affect its regulatory compliance?
Broder Bros., Co. is based in the United States. Since it manufactures medical devices, the company must comply with U.S. regulatory requirements, including those set by the FDA. While the location influences which regulations apply, the specific compliance depends on the device’s classification and intended use.
Which regulatory registries or databases list Broder Bros., Co.’s devices?
Broder Bros., Co.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning standardized identifiers, ensuring transparency and traceability in the healthcare supply chain.
How are Broder Bros., Co.’s devices classified under FDA regulations?
Broder Bros., Co.’s intermittent electronic patient thermometers fall under Class II classification by the FDA. This classification is based on the device’s risk level—Class II devices generally require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- primeline.com
- —
- —
- [email protected]
- Phone
- 1-800-873-7746
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 005381652
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Digital Thermometer | PL-1815 | FDA UDI | Class II | Active |
| Source Abroad | SA-700175 | FDA UDI | Class II | Active |
| PC600 Digital Thermometer - White | PC600 | FDA UDI | Class II | Active |
| Source Abroad | PL-2335 | FDA UDI | Class II | Active |
| Source Abroad | PL-2335 | FDA UDI | Class II | Active |
| Source Abroad | PL-2335 | FDA UDI | Class II | Active |
| Digital Thermometer | PL-1815 | FDA UDI | Class II | Active |
| Digital Thermometer | PL-1815 | FDA UDI | Class II | Active |
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