FDA Registration
Active
🇨🇳 China
UCOMFOR MEDICAL CO., LTD.
Reg #: 3009104075
·
FEI: 3009104075
·
Expires 2026
Products
17
Proprietary Names
19
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- UCOMFOR MEDICAL CO., LTD.
- Registration Number
- 3009104075
- FEI Number
- 3009104075
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm1208, No.76 Jiuxin Road , Shanghai, 201615, P.R.China
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K100846
Owner / Operator
- Firm Name
- Ucomfor Medical Co., Ltd.
- Operator Number
- 10038509
- Address
- Rm1208, No.76 Jiuxin Road , Shanghai, 201615, P.R.China
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201615
- Country
- CN
- Correspondent
- ZHENGYANG YI
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. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2011-10-20 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2011-10-19 |
| Device, Paste-On For Incontinence, Sterile | EXI | Class 1 | Gastroenterology, Urology | No | 2011-10-20 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2011-10-19 |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2011-10-20 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2011-10-19 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2011-10-20 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2011-10-20 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2011-10-20 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2011-10-20 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2013-04-03 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-12 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2012-09-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-03-23 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | Class 2 | Gastroenterology, Urology | No | 2011-10-19 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2022-05-22 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2011-10-20 |
Proprietary Names
Leg Bag
Bulb irrigation syringe 60cc, Enteral irrigation syringe 60cc, EAR BULB SYRINGE, Piston enteral irrigation syringe 60cc
Urine collector pediatric st, Urine Collector Sterile, Latex Free
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE
Urine collector pediatric 100ml
SUCTION YANKAUER with/without vent
Suction Yankauer, non-vented bulb tip, Sterile; Yankauer, non-vented regular tip, Sterile
Suction Tubing, Suction Connection Tubing
Connector, catheter
Urinary leg bag
Urinary drainage bag, DRAINAGE BAG
Irrigation syringe,Syringe Ear Ulcer
enema bag
Surgical Respirator, Mask
surgical brush
Surgical Mask
Urine meters
Vaginal Speculum
Enteral syringe, irrigation syringe
Establishment Types
Export Device to the United States But Perform No Other Operation on Device