FDA Registration
Active
🇳🇿 New Zealand
ENZTEC LIMITED
Reg #: 3004641308
·
FEI: 3004641308
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENZTEC LIMITED
- Registration Number
- 3004641308
- FEI Number
- 3004641308
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3/17 PRINT PLACE, MIDDLETON
- City
- CHRISTCHURCH Canterbury
- Country
- NZ
Regulatory Submissions
- 510(k) Number
- K152008
Owner / Operator
- Firm Name
- ENZTEC LIMITED
- Operator Number
- 9084846
- Address
- 3/17 Print Place, Middleton, --
- City
- Christchurch
- State
- Canterbury
- Postal Code
- 8024
- Country
- NZ
- Correspondent
- Kate - Moorhead
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2023-10-31 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)