Data / Medical devices / China / Guangzhou Berrcom Medical Device Co., Ltd
Guangzhou Berrcom Medical Device Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 4 510(k) clearances
Guangzhou Berrcom Medical Device Co., Ltd is registered with the FDA (registration 3008395508) in Guangzhou Guangdong, China. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008395508
- Address
- No.38 Huanzhen Xi Road, Dagang Town, Nansha, Guangzhou Guangdong, China, 511470
- Owner or operator
- Guangzhou Berrcom Medical Device Co., Ltd (10032524)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 17, 2013
- Registered through
- 2026
- Brand names listed
- Berrcom, Pulse Oximeter, YM302, Digital Basal Thermometer, Model: DT002, DT003, DT004, DT005, DT006;, Digital Thermometer, Model: DT001, DT007, DT008;, Digital Thermometer, Model: DT007, DT008, DT113, DT116, DT117, DT119;, Digital Thermometer, Model: DT101, DT102, Ear Thermometer, Model: ET001, MD-H30, ET003, ET005, ET008, ET009;, Ear Thermometer, Model: ET101, ET102, ET103, ET106, ET107, ET108;, Electronic Blood Pressure Monitor for Upper Arm, BPA001, BPA002 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2024 | K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 19, 2021 | K203593 | Patient Examination Gloves | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| December 7, 2020 | K202173 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 17, 2013 | K130232 | ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM | DXN | Substantially Equivalent | Jinxinbao Electronic Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Clinical Electronic Thermometer
- All makers of Irrigator, Powered Nasal
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Polymer Patient Examination Glove
- All makers of Oximeter
Updated July 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.