FDA Registration
Active
🇨🇳 China
Primecare Medical (Suzhou) Co.,Ltd.
Reg #: 3015337348
·
FEI: 3015337348
·
Expires 2026
Products
19
Proprietary Names
25
Establishment Types
1
Classifications
19
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Registration Details
- Registration Name
- Primecare Medical (Suzhou) Co.,Ltd.
- Registration Number
- 3015337348
- FEI Number
- 3015337348
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City, Jiangshu Province, PEOPLE'S REPUBLIC OF CHINA
- City
- Changshu Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Primecare Medical (Suzhou) Co.,Ltd.
- Operator Number
- 10059848
- Address
- Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City
- City
- Changshu
- State
- Jiangsu
- Postal Code
- 215532
- Country
- CN
- Correspondent
- Juan Wu
US Agent
- Business Name
- 3dstocking Inc
- Contact Name
- Wei ZHANG
- Address
- 3 Germay Dr Ste 5 Pmb 29339
- City
- Wilmington
- State
- DE
- ZIP
- 19804
- Country
- US
- [email protected]
- Phone
- 772 9996108
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2022-06-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2019-05-05 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2023-06-08 |
| Tracheostomy And Nasal Suctioning Kit | LRQ | Class 1 | Unknown | No | 2019-05-05 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2022-07-26 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2019-05-05 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2024-12-03 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2020-03-24 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2023-02-27 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-02-27 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-02-27 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2023-02-27 |
| Device, Paste-On For Incontinence, Sterile | EXI | Class 1 | Gastroenterology, Urology | No | 2022-06-28 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2020-04-14 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2019-05-05 |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2022-06-28 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2019-03-25 |
| Enema Kit | FCE | Class 1 | Gastroenterology, Urology | No | 2021-11-01 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2019-05-05 |
Proprietary Names
Suction Yankauer
Irrigation tray, Irrigation syringe, Ear Ulcer syringe
Enteral Specific transition connector
Medication Bottle Adaptor
Trachestomy care kit
Specimen container, STR
Skin Staple removal Kit; Suture removal kit /tray
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Urethral Catheterization Tray (w/ or w/o Catheter)
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab
Urine collector pediatric st
Speicmen Collector Urine/Stool, Non-Str; Specimen Container
Foley insertion tray
Catheter Care Tray
Urine collector pediatric NS
IV START KIT
Dressing change kit
Skin Scrub Tray
Convenience Kits
Central Line Trays
Shave Prep Kit
Instrument pack
Laceration tray
ENEMA BUCKET 1500ML W/SOAP; ENEMA SET
Suction catheter kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)