FDA Registration
Active
🇲🇾 Malaysia
ENCOMPASS INDUSTRIES SDN. BHD.
Reg #: 3014384460
·
FEI: 3014384460
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- ENCOMPASS INDUSTRIES SDN. BHD.
- Registration Number
- 3014384460
- FEI Number
- 3014384460
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 18256, KAWASAN PERINDUSTRIAN LOT Q, KERTIH BIO-POLYMER PARK
- City
- KEMAMAN Terengganu
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K120184
Owner / Operator
- Firm Name
- ENCOMPASS INDUSTRIES SDN. BHD.
- Operator Number
- 10057400
- Address
- LOT 18256, KAWASAN PERINDUSTRIAN LOT Q, KERTIH BIO-POLYMER PARK
- City
- KEMAMAN
- State
- Terengganu
- Postal Code
- 24300
- Country
- MY
- Correspondent
- Nicholas Wang
US Agent
- Business Name
- Encompass Medical Supplies Inc
- Contact Name
- Jordan Chang
- Address
- 1930 Brea Canyon Road, No. 240, Diamond Bar , CA 91765
- City
- Diamond Bar
- State
- CA
- ZIP
- 91765
- Country
- US
- [email protected]
- Phone
- 909 8601908
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2020-11-04 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2020-11-04 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-01-07 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-05-31 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-07-15 |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | Class 1 | General Hospital | No | 2025-07-15 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-07-15 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device