FDA Registration
Active
🇨🇳 China
UCOMFOR SCIENTIFIC CO.,LTD
Reg #: 3016884033
·
FEI: 3016884033
·
Expires 2026
Products
13
Proprietary Names
16
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- UCOMFOR SCIENTIFIC CO.,LTD
- Registration Number
- 3016884033
- FEI Number
- 3016884033
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lekun Road, Leyu Town
- City
- Zhangjiagang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K050887
Owner / Operator
- Firm Name
- Ucomfor Scientific Co.,Ltd
- Operator Number
- 10067128
- Address
- Lekun Road, Leyu Town
- City
- Zhangjiagang
- State
- Jiangsu
- Postal Code
- 215621
- Country
- CN
- Correspondent
- Ava Wu
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St. WU
- Address
- 1942 Broadway St., STE 314C,
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2021-03-29 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2021-12-23 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2022-01-27 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2022-05-19 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-04-03 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2021-12-23 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2021-12-23 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2021-12-23 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2021-12-23 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-04-15 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-03 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2025-07-23 |
| Device, Paste-On For Incontinence, Sterile | EXI | Class 1 | Gastroenterology, Urology | No | 2021-12-23 |
Proprietary Names
Drainage bags
Urinary drainage bag 500cc-2000cc , Urinary Leg bag, Drainage Bag
Connector
Vaginal Speculum
Surgical face mask
SUCTION YANKAUER, Yankauer, non-vented bulb/regular tip, Sterile,Yankauer, vented bulb/regular tip
Suct instr yank blb w/o vent, Yankauer, vented regular tip, Sterile, Latex Free, Suct instr yank reg w vent
Vaginal speculum
Thumb control piston irrigation syringe 60cc ST, Bulb irrigation syringe 60cc ST, Flat top piston irrigation syringe 60c
Urine meters
TUBE, ASPIRATING, FLEXIBLE, CONNECTING, Suction conneting tube, Suction Tubing
Mask, Scavenging
Face Mask
Feeding tubes, Nasoenteric Feeding Tubes
Urine collector pediatric sterile
Enteral Extension Sets
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)