FDA Registration
Active
🇲🇾 Malaysia
SCOPE MANUFACTURERS (M) SDN. BHD
Reg #: 3007036637
·
FEI: 3007036637
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SCOPE MANUFACTURERS (M) SDN. BHD
- Registration Number
- 3007036637
- FEI Number
- 3007036637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 6181 Jalan Perusahaan 2, Kawasan Perindustrian Parit Buntar
- City
- Parit Buntar Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K202339
Owner / Operator
- Firm Name
- SCOPE MANUFACTURERS (M) SDN. BHD
- Operator Number
- 10077401
- Address
- Lot 6181 Jalan Perusahaan 2, Kawasan Perindustrian Parit Buntar
- City
- Parit Buntar
- State
- Perak
- Postal Code
- 34200
- Country
- MY
- Correspondent
- YI HAO LIM
US Agent
- Business Name
- Inventec Appliances Corporation USA, Inc.
- Contact Name
- Paul Wang
- Address
- 2880 Lakeside Dr, Ste 203, Santa Clara, CA 95054
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
- [email protected]
- Phone
- 408 2138100
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Purifier, Air, Ultraviolet, Medical | FRA | Class 2 | General Hospital | No | 2021-03-01 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)