FDA Registration
Active
🇮🇩 Indonesia
PT YWANJAN TECHNOLOGY
Reg #: 3038185756
·
FEI: 3038185756
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PT YWANJAN TECHNOLOGY
- Registration Number
- 3038185756
- FEI Number
- 3038185756
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GP78+5C5, Teluk Meranti,
- City
- Pelalawan Regency Riau
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K243792
Owner / Operator
- Firm Name
- PT YwanJan TECHNOLOGY
- Operator Number
- 10093196
- Address
- GP78+5C5, Teluk Meranti,
- City
- Pelalawan Regency
- State
- Riau
- Postal Code
- 28353
- Country
- ID
- Correspondent
- Benjamin Wilson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-04-13 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-04-13 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-04-13 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-04-13 |
Proprietary Names
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device