FDA Registration
Active
🇲🇾 Malaysia
URO TECHNOLOGY SDN. BHD.
Reg #: 3004070478
·
FEI: 3004070478
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- URO TECHNOLOGY SDN. BHD.
- Registration Number
- 3004070478
- FEI Number
- 3004070478
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 2491 BATU 39 1/2, PONTIAN BESAR
- City
- PONTIAN Johor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K071423
Owner / Operator
- Firm Name
- URO TECHNOLOGY SDN. BHD.
- Operator Number
- 10058118
- Address
- Lot 2491, Batu 39 1/2, Pontian Besar
- City
- Pontian
- State
- Johor
- Postal Code
- 82000
- Country
- MY
- Correspondent
- Khairunnisa Warsito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-12-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)