FDA Registration
Active
🇹🇼 Taiwan
New Deantronics Taiwan Ltd. - Chiayi
Reg #: 3016099036
·
FEI: 3016099036
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- New Deantronics Taiwan Ltd. - Chiayi
- Registration Number
- 3016099036
- FEI Number
- 3016099036
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 16, Machouhou Yuancyu 1st Rd., Lucao Township
- City
- Chiayi County
- Country
- TW
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 | 2024-04-18 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2024-04-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2025-06-23 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-10-10 |
Proprietary Names
Neuroblade System
disposable handswitch pencil
electrosurgical cutting and coagulation accessories
Hawkeye Control Unit with Eyas Endoscope
Lucky Strike
Dist Rib Clear cannula with oburator
cannula with oburator
MACB Dual Slotted Cannula & Cannulated Trochar MI22
threaded clear cannula with oburator
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)