Primecare Medical (Suzhou) Co., Ltd.
Registered establishment in Changshu, Jiangsu, China. 20 device types.
Primecare Medical (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Uroflowmeter and 18 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | Primecare Medical (Suzhou) Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015337348 |
| FEI number | 3015337348 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changshu |
|---|---|
| Province | Jiangsu |
| Address | Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City |
| Postal code | 215532 |
| 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 | 2024 | 58 |
| Catheter And Tip, Suction | Class 2 | Suction Yankauer | 2022 | 70 |
| Catheter Care Tray | Class 2 | Catheter Care Tray, Foley insertion tray | 2019 | 12 |
| Catheter, Retention Type, Balloon | Class 2 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab | 2023 | 17 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction catheter kit | 2019 | 93 |
| Container, Specimen, Non-Sterile | Class 1 | Speicmen Collector Urine/Stool, Non-Str; Specimen Container | 2020 | 115 |
| Container, Specimen, Sterile | Class 1 | Specimen container, STR | 2022 | 79 |
| Device, Paste-On For Incontinence, Non-Sterile | Class 1 | Urine collector pediatric NS | 2022 | 13 |
| Device, Paste-On For Incontinence, Sterile | Class 1 | Urine collector pediatric st | 2022 | 12 |
| Dispenser, Liquid Medication | Class 1 | Enteral Specific transition connector, Medication Bottle Adaptor | 2023 | 86 |
| Enema Kit | Class 1 | Enema Bucket 1500ML W/Soap; Enema SET | 2021 | 24 |
| Intra-Abdominal Pressure Monitoring Device | Class U | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab | 2023 | 4 |
| Kit, Surgical Instrument, Disposable | Class 1 | Laceration tray, Central Line Trays, Skin Scrub Tray, Shave Prep Kit, IV Start KIT, Dressing change kit and 2 more | 2019 | 67 |
| Medical Device Data System | Class 1 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab | 2023 | 11 |
| 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 | 2019 | 110 |
| Tracheostomy And Nasal Suctioning Kit | Class 1 | Trachestomy care kit | 2019 | 6 |
| 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 | Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab | 2023 | 7 |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 4000m² warehouse, 2200m² clean room |
|---|---|
| Main products | medical device kits, instrument trays, prefilled syringes |
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.