FDA Registration
Active
🇻🇳 Vietnam
KANEKA MEDICAL VIETNAM Co.,Ltd.
Reg #: 3031550970
·
FEI: 3031550970
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- KANEKA MEDICAL VIETNAM Co.,Ltd.
- Registration Number
- 3031550970
- FEI Number
- 3031550970
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35 VSIP Street 6, Vietnam - Singapore Industrial Park, An Phu Word
- City
- Ho Chi Minh
- 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 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2021-03-28 |
| Device, Neurovascular Embolization | HCG | Class 2 | Neurology | No | 2021-03-28 |
Proprietary Names
OTW Takeru
RX Takeru
EDG v4
i-ED COIL
RX NC Takeru
Establishment Types
Manufacture Medical Device