Primecare Medical (Huzhou) Co., Ltd.
Registered establishment in Hu Zhou, Zhejiang, China. 9 device types.
Primecare Medical (Huzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Lubricant, Patient, Pump, Infusion, Enteral and 7 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | Primecare Medical (Huzhou) Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031190571 |
| FEI number | 3031190571 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Hu Zhou |
|---|---|
| Province | Zhejiang |
| Address | No. 398 Guang Yuan Road, Wu Xing District, 313099 Huzhou, PEOPLE’S REPUBLIC OF CHINA |
| Postal code | 313099 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Leg bag | 2024 | 52 |
| Catheter And Tip, Suction | Class 2 | Suction Yankauer | 2026 | 70 |
| Catheter, Retention Type, Balloon | Class 2 | Prefilled Syringe | 2024 | 17 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | BAG, URINARY DRAIN Urinary drainage Bag Holder | 2024 | 51 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Extension Set, Enteral feeding sets | 2024 | 17 |
| Lubricant, Patient | Class 1 | Lub Jelly Syringe | 2024 | 33 |
| Pump, Infusion, Enteral | Class 2 | Enteral feeding pump sets | 2025 | 5 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction connecting tube Extension tube | 2024 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Enteral feeding sets | 2024 | 25 |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 4000 m² warehouse, 2200 m² clean room |
|---|---|
| Main products | pre-filled syringes, urine bags, medical catheters, medical kits |
| Certifications | ISO quality management system |
| Export markets | USA, EU, Asia Pacific |
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.