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Sign in to claim this brandGuangzhou Berrcom Medical Device Co., Ltd
US
Last updated May 30, 2026
What Guangzhou Berrcom Medical Device Co., Ltd makes
The company manufactures non-invasive temperature measurement devices, including infrared skin and ear thermometers, as well as electric nasal aspirators for infants. It also produces intermittent electronic thermometers for clinical use and an enzyme immunoassay (EIA) kit for identifying HLA class II antibodies, used in immunology testing.
These products are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a presence 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 Guangzhou Berrcom Medical Device Co., Ltd manufacture?
Guangzhou Berrcom Medical Device Co., Ltd specializes in non-invasive medical devices. Their portfolio includes infrared thermometers for measuring skin and ear temperatures, intermittent electronic thermometers for clinical settings, and electric nasal aspirators designed for infant use. Additionally, they produce an enzyme immunoassay (EIA) kit for HLA class II antibody identification, which is used in immunology testing to assess immune system compatibility.
Where is Guangzhou Berrcom Medical Device Co., Ltd based, and does it operate in the United States?
The company is based in Guangzhou, China, but it has a presence in the United States. While the headquarters is not located in the US, its products are distributed and used there, including devices regulated by the FDA.
Which regulatory registries list devices manufactured by Guangzhou Berrcom Medical Device Co., Ltd?
Devices from Guangzhou Berrcom Medical Device Co., Ltd are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for healthcare providers and regulators.
How are the devices produced by Guangzhou Berrcom Medical Device Co., Ltd classified under FDA regulations?
The company’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose the lowest risk and often require minimal regulatory controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 529391821
Catalogue (103)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Berrcom | DT101 | FDA UDI | Class II | Active |
| Utopia | JXB-182 | FDA UDI | Class II | Active |
| Rycom | JXB-190 | FDA UDI | Class II | Active |
| Kaiser Permanente | JXB-182 | FDA UDI | Class II | Active |
| Snomd | JXB-302 | FDA UDI | Class II | Active |
| Berrcom | NC007 | FDA UDI | Class I | Active |
| Berrcom | JXB-178 | FDA UDI | Class II | Active |
| Berrcom | JXB-183 | FDA UDI | Class II | Active |
| Rycom | JXB-189 | FDA UDI | Class II | Active |
| Homewell Essentials | JXB-183 | FDA UDI | Class II | Active |
| homewell ESSENTIALS | JXB-183 | FDA UDI | Class II | Active |
| Rightcare | JXB-178 | FDA UDI | Class II | Active |
| Lifechek | JXB-188 | FDA UDI | Class II | Active |
| Berrcom | JXB-178 | FDA UDI | Class II | Active |
| Alertcare | JXB-178 | FDA UDI | Class II | Active |
| Berrcom | NC005 | FDA UDI | Class I | Active |
| Rycom | JXB-182 | FDA UDI | Class II | Active |
| Berrcom | JXB-302 | FDA UDI | Class II | Active |
| Berrcom | JXB-313 | FDA UDI | Class II | Active |
| Snomd | JXB-183 | FDA UDI | Class II | Active |
| Berrcom | ET005 | FDA UDI | Class II | Active |
| Berrcom | JXB-190 | FDA UDI | Class II | Active |
| Baby Cove | NC001 | FDA UDI | Class I | Active |
| Berrcom | DT007 | FDA UDI | Class II | Active |
| Wevapers | JXB-313 | FDA UDI | Class II | Active |
| Rycom | JA001 | FDA UDI | Class II | Active |
| Accumed | AT2102 | FDA UDI | Class II | Active |
| WeVapers | JXB-183 | FDA UDI | Class II | Active |
| Jonterking | JXB-195 | FDA UDI | Class II | Active |
| Berrcom | JXB-178 | FDA UDI | Class II | Active |
| Rycom | JA111 | FDA UDI | Class II | Active |
| Linktemp | JXB-305 | FDA UDI | Class II | Active |
| Jonterking | JXB-182 | FDA UDI | Class II | Active |
| Eco4us | EM-Th1 | FDA UDI | Class II | Active |
| Intey | NY-BG16 | FDA UDI | Class I | Active |
| Bp | ET107 | FDA UDI | Class II | Active |
| Elcare | JXB-311 | FDA UDI | Class II | Active |
| Rycom | JXB-191 | FDA UDI | Class II | Active |
| Rycom | JXB-183 | FDA UDI | Class II | Active |
| Berrcom | JXB-311 | FDA UDI | Class II | Active |
| vaxxen | JXB-178 | FDA UDI | Class II | Active |
| Cocobear | BY-01 | FDA UDI | Class II | Active |
| Sprucely | DT113 | FDA UDI | Class II | Active |
| kidz&bellz | JXB-311 | FDA UDI | Class II | Active |
| Hylogy | BY-01 | FDA UDI | Class II | Active |
| Berrcom | DT007 | FDA UDI | Class II | Active |
| Rycom | ET001 | FDA UDI | Class II | Active |
| Veritas Accutemp | GAT1124 | FDA UDI | Class II | Active |
| Eco4us | EM-Th1 | FDA UDI | Class II | Active |
| Hylogy | MD-H26 | FDA UDI | Class II | Active |
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