FDA Registration
Active
🇲🇾 Malaysia
Soft Tips
Reg #: 3007744213
·
FEI: 3007744213
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Profound Rubber Ind Sdn Bhd
- Registration Number
- 3007744213
- FEI Number
- 3007744213
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 1953 Lorong Bukit Minyak IKS3, Juru
- City
- Seberang Perai Tengah Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K992998
Owner / Operator
- Firm Name
- Profound Rubber Ind Sdn Bhd
- Operator Number
- 10029448
- Address
- No. 1953 Lorong Bukit Minyak IKS3, Juru
- City
- Seberang Perai Tengah
- State
- Pulau Pinang
- Postal Code
- 14100
- Country
- MY
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2010-03-17 |
Proprietary Names
Soft Tips
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)