FDA Registration
Active
🇻🇳 Vietnam
OTW Takeru
Reg #: 3031550970
·
FEI: 3031550970
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KANEKA MEDICAL VIETNUM Co.,Ltd.
- Registration Number
- 3031550970
- FEI Number
- 3031550970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 35 VSIP Street 6, Vietnum - Singapore Industrial Park, An Phu Ward
- City
- Thuan An Binh Duong
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K172264
Owner / Operator
- Firm Name
- KANEKA CORP.
- Operator Number
- 9005249
- Address
- 2-3-18, Nakanoshima, Kita-ku
- City
- Osaka
- State
- JP-27
- Postal Code
- 530-8288
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2018-03-19 |
Proprietary Names
OTW Takeru
Establishment Types
Manufacture Medical Device