Guangdong Biolight Meditech Co., Ltd.
Guangdong Biolight Meditech Co., Ltd. has 0 FDA recalls, 2 inspections, 21 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Apr 14, 2016 · NAI
- Latest 510(k)
- Apr 5, 2019
Reviewing Guangdong Biolight Meditech Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Guangdong Biolight Meditech Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 21 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 14, 2016 | Zhuhai, China | Devices | No Action Indicated (NAI) | 3007305624 |
| Mar 20, 2014 | Zhuhai, China | Devices | Voluntary Action Indicated (VAI) | 3007305624 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Guangdong Biolight Meditech Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007305624 | Zhuhai, China | 2 | Apr 14, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K181919 | Patient Monitor | Apr 5, 2019 |
| K170514 | Central Monitoring System | May 24, 2017 |
| K162234 | Truscope Ultra Patient Monitor | Jan 4, 2017 |
| K160349 | Electronic Sphygmomanometer | Nov 3, 2016 |
| K153580 | Central Monitoring System | Sep 7, 2016 |
| K153135 | VITAL SIGNS MONITOR | Feb 25, 2016 |
| K152739 | Electronic Thermometer | Feb 9, 2016 |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | Jan 6, 2016 |
| K131858 | DIGITAL ELECTROCARDIOGRAPH | Jun 11, 2014 |
| K131762 | HANDHELD MONITOR | Jun 6, 2014 |
| K131941 | FETAL MONITORS | May 15, 2014 |
| K131898 | A SERIES AND Q SERIES PATIENT MONITORS | Feb 18, 2014 |
| K131763 | TRUSCOPE SERIES PATIENT MONITOR | Jul 15, 2013 |
| K120193 | ANY VIEW PATIENT MONITORS | Jun 29, 2012 |
| K113833 | VITAL SIGNS MONITOR | May 1, 2012 |
| K112804 | FINGERTIP PULSE OXIMETER | Jan 27, 2012 |
| K112803 | PATIENT MONITOR | Oct 24, 2011 |
| K102040 | PATIENT MONITOR | Sep 24, 2010 |
| K101694 | HANDHELD PULSE OXIMETER MODEL M800 | Sep 8, 2010 |
| K100046 | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 | Apr 8, 2010 |
Need more than this page shows? Ask about Guangdong Biolight Meditech Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.