Guangdong Baihe Medical Technology Co., Ltd.
Manufacturer and brand owner in Foshan, Guangdong, China. 4 device types, 24 products catalogued, 1 clearance.
Guangdong Baihe Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dressing, Wound, Hydrophilic, Catheter, Retention Type, Balloon and 2 other device types. 24 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006621386 |
| FEI number | 3006621386 |
| DUNS | 547055364 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广东百合医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91440600721123254C |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | No.89 Taoyuan East Rd, Nanhai |
| Postal code | 528225 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Hemodialysis, Non-Implanted | Class 2 | Disposable Hemodialysis Access Catheter Set | 2011 | 1 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | Able Central Venous Catheter | 2007 | 12 |
| Catheter, Retention Type, Balloon | Class 2 | Disposable Silicone Foley Catheter | 2013 | 17 |
| Dressing, Wound, Hydrophilic | Class 1 | CMC Wound Dressing | 2023 | 195 |
Own-Brand Listings
Clearances
1 clearance names Guangdong Baihe Medical Technology Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K130908 | 2013-10-03 | EZL | Traditional | This company |
| K102833 | 2011-11-18 | MPB | Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. |
| K070451 | 2007-07-31 | FOZ | Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Employees | 2000-3000 |
| Factory area | 40000 sq m |
| Main products | Central venous catheter, Hemodialysis catheter, Blood line, PICC catheter, Medical consumables |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.