Hangzhou Primecare Medical Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 29 device types, 2 clearances.
Hangzhou Primecare Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Uroflowmeter and 27 other device types. Its earliest product listing with the FDA dates from 2018.
29device types registered with the FDA
2510(k) clearances
Registration
| Registered name | Hangzhou Primecare Medical Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014637079 |
| FEI number | 3014637079 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 杭州派瑞科医疗器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | Room 408-409, Zancheng Center West, Shangcheng District, 310008 Hangzhou, PEOPLE’S REPUBLIC OF CHINA |
| Postal code | 310008 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Apparatus, Suction, Single Patient USE, Portable, Nonpowered | 2018 | 58 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Leg Bag, Drainage Bag, Urinary Drainage Bag | 2018 | 52 |
| Catheter And Tip, Suction | Class 2 | Suction Yankauer | 2018 | 70 |
| Catheter Care Tray | Class 2 | Catheter Care Tray, Foley insertion tray | 2018 | 12 |
| Catheter, Retention Type, Balloon | Class 2 | Pre-filled syringe, Urine Meter Drainage Bag;Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Te, Latex Foley catheters, Silicone Foley catheters | 2019 | 17 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction catheter kit | 2019 | 93 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | 2018 | 51 | |
| Container, Specimen, Non-Sterile | Class 1 | Speicmen Collector Urine/Stool, Non-Str; Specimen Container | 2018 | 115 |
| Container, Specimen, Sterile | Class 1 | Specimen container, STR | 2018 | 79 |
| Device, Paste-On For Incontinence, Non-Sterile | Class 1 | Urine collector pediatric NS | 2018 | 13 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine collector pediatric st | 2018 | 12 |
| Dispenser, Liquid Medication | Class 1 | Medication Bottle Adaptor, Enteral Specific transition connector | 2021 | 86 |
| Enema Kit | Class 1 | Enema Bucket 1500ML W/Soap; Enema SET | 2018 | 24 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Enteral feeding sets, Extension Set | 2018 | 17 |
| Intra-Abdominal Pressure Monitoring Device | Class U | Urine Meter Drainage Bag;Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Te | 2023 | 4 |
| Kit, Surgical Instrument, Disposable | Class 1 | IV Start KIT, skin scrub Tray, Laceration Tray, Shave Prep Kit, Convenience Kits, Dressing change kit and 2 more | 2018 | 67 |
| Lubricant, Patient | Class 1 | Lub Jelly Syringe | 2020 | 33 |
| Medical Device Data System | Class 1 | Urine Meter Drainage Bag;Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Te | 2023 | 11 |
| Pump, Infusion, Enteral | Class 2 | Enteral feeding pump sets | 2025 | 5 |
| Razor, Surgical | Class 1 | razor prep disposable, razor twin blade | 2025 | 34 |
| Speculum, Vaginal, Nonmetal | Class 2 | Disposable Vaginal Speculum | 2025 | 40 |
| Suture Removal Kit | Class 1 | Skin Staple removal Kit; Suture removal kit /tray | 2019 | 12 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigation tray, irrigation syringe, Ear Ulcer syringe | 2018 | 110 |
| Tracheostomy And Nasal Suctioning Kit | Class 1 | Trachestomy care kit | 2019 | 6 |
| Tube, Aspirating, Flexible, Connecting | Class 2 | Suction connecting tube; Extension tube | 2018 | 51 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Enteral feeding sets | 2018 | 25 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | Class 2 | Urethral Catheterization Tray (w/ or w/o Catheter) | 2020 | 11 |
| Urine Collection Kit (Excludes Hiv Testing) | Class 1 | Midstream Specimen Catch Kit | 2024 | 7 |
| Uroflowmeter | Class 2 | Urine Meter Drainage Bag;Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Te | 2023 | 7 |
Clearances
2 clearances name Hangzhou Primecare Medical Co., Ltd. as applicant. 5 are held by other companies 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 |
|---|---|---|---|---|
| K240039 | 2024-04-17 | KNT | Traditional | This company |
| K202698 | 2020-12-15 | EZL | Traditional | This company |
| K232205 | 2023-10-23 | LZH | Traditional | Vesco Medical LLC |
| K221020 | 2023-01-13 | EZL | Traditional | Potrero Medical, Inc. |
| K192991 | 2020-08-03 | PIF | Traditional | Vesco Medical LLC |
| K181276 | 2018-07-12 | PIF | Traditional | Conod Medical Co., Limited |
| K082815 | 2008-10-08 | EZL | Traditional | Well Lead Medical Instruments |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2017 |
|---|---|
| Main products | Medical device kits, Prefilled syringes, Maternal infant health services |
| Certifications | National Health Service Standard Training Base |
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.
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