FDA Registration
Active
🇨🇳 China
UNISOURCE SHANGHAI LTD.
Reg #: 3007165189
·
FEI: 3007165189
·
Expires 2026
Products
23
Proprietary Names
38
Establishment Types
3
Classifications
23
Registration Details
- Registration Name
- UNISOURCE SHANGHAI LTD.
- Registration Number
- 3007165189
- FEI Number
- 3007165189
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bldg.#2, ROOM 802 Huayi Building, No.2020 Zhongshan Road West, Shanghai 200235 China
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K063666
Owner / Operator
- Firm Name
- Unisource Shanghai Ltd.
- Operator Number
- 10027023
- Address
- Room 1416 Fortune Times Square,, No.1438 North Sanxi Road, Putuo Dist.,
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200060
- Country
- CN
- Correspondent
- Julia Wu
US Agent
- Business Name
- medapproval llc
- Contact Name
- william slevin
- Address
- 730 E Suber Rd
- City
- Greer
- State
- SC
- ZIP
- 29650
- Country
- US
- [email protected]
- Phone
- 404 5935005
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-12-11 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-07-29 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2021-03-09 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-07-29 |
| Floss, Dental | JES | Class 1 | Dental | No | 2008-09-17 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-24 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2023-07-29 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2025-09-17 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2023-05-09 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2010-06-17 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2026-05-02 |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | Class 1 | Dental | No | 2023-05-31 |
| Container, Sharps | MMK | Class 2 | General Hospital | No | 2016-01-12 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2008-09-17 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2012-05-23 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2023-04-09 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2025-12-11 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-04-03 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2011-05-24 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2022-07-16 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-07-29 |
| Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | NKJ | Class 1 | Dental | No | 2012-05-23 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2018-01-08 |
Proprietary Names
Mouth Mate
Comfort Soft Large
Tongue-Guide Standard Pro
Comfort Soft Small
Tongue-Guide Infant Home
Tongue-Guide Infant Pro
Shoecovers, Overshoes
Dental Wax
Orthodontic Wax
Bouffant Caps, Mop Caps, Doctor Caps,
Dental Floss
Accessory, Surgical Apparel - Non-woven Face Masks
Teeth Whitening Strips
Refill-Ease
Lock N Reload
LED Headlight System
Face Masks, 3 Layer Flat
Angle-Ease Ejector
Toothbrush Sanitizer
Toothbrushes Adult & Kids
Toothbrush Powered, Eletricity Toothbrush
Scan-Mate (Blue)
Scan-Mate MegaGen
Scan-Mate (Black)
TissuePro Single Sleeve, MN Retrator
TissuePro Distal Sleeve, MN Retractor Single-Use;
TissuePro Distal Sleeve, MN Retractor
TissuePro Proximal Sleeve, MN Retractor
Face Shield
MirrorSoft No.5 Mirror
MirrorSoft No.5 Double Mirror
DENTAL MIRROR, DENTAL MOUTH MIRROR
MirrorSoft TearDrop Mirror
MirroSoft No.4 Mirror
Aligner Chewies
Aligner Hook / Remover
Non-surgical Isolation Gown
Tongue Scraper
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Reprocess Single-Use Device
Repack or Relabel Medical Device