FDA Registration
Active
🇹🇼 Taiwan
Lucky Strike
Reg #: 3016099036
·
FEI: 3016099036
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- New Deantronics Taiwan Ltd. - Chiayi
- Registration Number
- 3016099036
- FEI Number
- 3016099036
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 16, Machouhou Yuancyu 1st Rd., Lucao Township
- City
- Chiayi County
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K240572
Owner / Operator
- Firm Name
- NEW DEANTRONICS TAIWAN LTD.
- Operator Number
- 9020358
- Address
- 12F. No.51, Sec. 4, Zhongyang Rd., Tucheng Dist.
- City
- New Taipei City
- State
- TW-NOTA
- Postal Code
- 236
- Country
- TW
US Agent
- Business Name
- New Deantronics, Ltd.
- Contact Name
- TINA LO
- Address
- 1 New Deantronics Way
- City
- Sparks
- State
- NV
- ZIP
- 89441
- Country
- US
- [email protected]
- Phone
- 775 4331808
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-07-18 |
Proprietary Names
Lucky Strike
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)