FDA Registration
Active
🇨🇦 Canada
Revanesse Gel Pack
Reg #: 3004423487
·
FEI: 3004423487
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PROLLENIUM MEDICAL TECHNOLOGIES INC.
- Registration Number
- 3004423487
- FEI Number
- 3004423487
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 138 Industrial Pkwy N.
- City
- Aurora Ontario
- Country
- CA
Owner / Operator
- Firm Name
- Prollenium Medical Technologies Inc.
- Operator Number
- 10055618
- Address
- 138 Industrial Pkwy N.
- City
- Aurora
- State
- Ontario
- Postal Code
- L4G4C3
- Country
- CA
- Correspondent
- Timothy Lee
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 |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-04-22 |
Proprietary Names
Revanesse Gel Pack
Establishment Types
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device