FDA Registration
Active
🇹🇼 Taiwan
Shummi Enterprise Co., Ltd.
Reg #: 3005816808
·
FEI: 3005816808
·
Expires 2026
Products
10
Proprietary Names
12
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- Shummi Enterprise Co., Ltd.
- Registration Number
- 3005816808
- FEI Number
- 3005816808
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13F-1, No. 188 Nanking E Road, Sec. 5, Taipei 105, Taiwan, R.O.C.
- City
- Taipei
- Country
- TW
Owner / Operator
- Firm Name
- Shummi Enterprise Co, Ltd
- Operator Number
- 9007361
- Address
- 13F-1 No. 188 Nanking Road Section 5
- City
- Taipei 105
- State
- TW-TPE
- Postal Code
- 105
- Country
- TW
US Agent
- Business Name
- LUCKY CHIN INC.
- Contact Name
- A.W. Gebhard
- Address
- 2101 E Alameda Ave
- City
- Denver
- State
- CO
- ZIP
- 80209
- Country
- US
- [email protected]
- Phone
- 303 7771819
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pick, Massaging | JET | Class 1 | Dental | No | 2017-08-08 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2007-03-06 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2022-08-02 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2007-03-06 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2011-01-26 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2007-03-06 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2007-03-22 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2012-07-03 |
| Floss, Dental | JES | Class 1 | Dental | No | 2007-03-06 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2007-03-06 |
Proprietary Names
Comfort Picks
Metal Tongue Scraper
ENFRESH ORIGINAL TONGUE BRUSH
Applicator, Butt Brush
MOUTH DENTAL
Explorer
MANUAL TOOTHBRUSH
Pre-pasted toothbrush
DENTAL WAX
Super Dental Kit
Dental Floss
POWERED DENTAL
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)