FDA Registration
Active
🇨🇦 Canada
Revanesse Versa
Reg #: 3019585045
·
FEI: 3019585045
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Prollenium Medical Technologies Inc.
- Registration Number
- 3019585045
- FEI Number
- 3019585045
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 29 East Wilmot Street
- City
- Richmond Hill Ontario
- Country
- CA
Regulatory Submissions
- PMA Number
- P160042
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 |
|---|---|---|---|---|---|
| Implant, Dermal, For Aesthetic Use | LMH | Class 3 | Unknown | No | 2017-08-23 |
Proprietary Names
Revanesse Versa
Revanesse Versa+ with Lidocaine
Revanesse Versa+ with Lidocaine 1.2 mL
Revanesse® Lips + with Lidocaine
Revanesse® Versa 1.2 mL
Revanesse® Lips + with Lidocaine 1.2 mL
Establishment Types
Manufacture Medical Device