FDA Registration
Active
🇲🇾 Malaysia
YTY INDUSTRY (MANJUNG) SDN. BHD.
Reg #: 9613997
·
FEI: 3002563423
·
Expires 2026
Products
4
Proprietary Names
10
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- YTY INDUSTRY (MANJUNG) SDN. BHD.
- Registration Number
- 9613997
- FEI Number
- 3002563423
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 1422-1424, BATU 10 LEKIR
- City
- SITIAWAN Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K241909
Owner / Operator
- Firm Name
- YTY INDUSTRY SDN BHD
- Operator Number
- 8041009
- Address
- LOT 1422-1424, BATU 10 LEKIR
- City
- SITIAWAN,
- State
- Perak
- Postal Code
- 32020
- Country
- MY
- Correspondent
- Punitha Samy
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2015-11-02 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-12-18 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-12-18 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-12-18 |
Proprietary Names
Purple 9.5
HandsOn EZ-Off
EZDoff
EZDoffy
Critical Response
CR911
Critical Response High Visibility Gloves
BISM Critical Response Nitrile Exam Gloves
CURAD Versatile
CUR9311
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device