FDA Registration
Active
🇭🇰 Hong Kong
KI. WORKS VIETNAM CO., LTD
Reg #: 3011545201
·
FEI: 3011545201
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- KI. WORKS VIETNAM CO., LTD
- Registration Number
- 3011545201
- FEI Number
- 3011545201
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm. 1702, Sino Centre, 582-592 Nathan Rd
- City
- Mongkok, Kln., Hong Kong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K123849
Owner / Operator
- Firm Name
- Ki. WORKS VIETNAM CO., LTD
- Operator Number
- 10048361
- Address
- Rm. 1702, Sino Centre, 582-592 Nathan Rd
- City
- Mongkok, Kln., Hong Kong
- State
- HK-NOTA
- Postal Code
- 000000
- Country
- HK
- Correspondent
- Donald Lin
US Agent
- Business Name
- Compliance Engineering, Inc.
- Contact Name
- Ken Grant
- Address
- 2611 Merrick Rd #66
- City
- Bellmore
- State
- NY
- ZIP
- 11710
- Country
- US
- [email protected]
- Phone
- 516 9847287
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2015-01-05 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2015-01-05 |
| Floss, Dental | JES | Class 1 | Dental | No | 2015-01-05 |
| Mouthguard, Over-The-Counter | OBR | Class U | Unknown | No | 2021-12-17 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2015-01-05 |
Proprietary Names
REACH Professional Floss Picks 90
REACH Professional Floss Picks Mint 3CT
REACH Professional Floss Picks Mint 2CT
REACH Professional Comfy Picks 60
REACH Professional Interdental Brush Tight 10
REACH Professional Interdental Brush Tight 2CT
REACH Professional Interdental Brush Wide 10
REACH Professional Interdental Brush Wide 2CT
REACH Professional Interdental Brush Extra Tight 2CT
REACH Professional Interdental Brush Extra Tight 10
Establishment Types
Export Device to the United States But Perform No Other Operation on Device