Data / Medical devices / China / Guangdong Baihe Medical Technology Co., Ltd
Guangdong Baihe Medical Technology Co., Ltd: FDA-registered device maker in Foshan Guangdong, China, 3 510(k) clearances
Guangdong Baihe Medical Technology Co., Ltd is registered with the FDA (registration 3006621386) in Foshan Guangdong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 3, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006621386
- Address
- No.89 Taoyuan East Rd, Nanhai, Foshan Guangdong, China, 528225
- Owner or operator
- Guangdong Baihe Medical Technology Co., Ltd. (9097900)
- Roles
- Contract sterilizer, Exporter to the US, Manufacturer
- First device listed
- September 14, 2007
- Registered through
- 2026
- Brand names listed
- ABLE CENTRAL VENOUS CATHETER, CMC Wound Dressing, Disposable Hemodialysis Access Catheter Set, Disposable Silicone Foley Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Hemodialysis, Non-Implanted | MPB | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Retention Type, Balloon | EZL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| October 3, 2013 | K130908 | DISPOSABLE SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | Guangdong Baihe Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 18, 2011 | K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | MPB | Substantially Equivalent | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 31, 2007 | K070451 | ABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Hemodialysis, Non-Implanted
- All makers of Dressing, Wound, Hydrophilic
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Retention Type, Balloon
Updated October 3, 2013. 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.