FDA Registration
Active
🇪🇸 Spain
HIGH TECHNOLOGY PRODUCTS, SLU
Reg #: 3016413636
·
FEI: 3016413636
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- HIGH TECHNOLOGY PRODUCTS, SLU
- Registration Number
- 3016413636
- FEI Number
- 3016413636
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carrer del Gall, 22
- City
- Esplugues de Llobregat Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K191321
Owner / Operator
- Firm Name
- High Technology Products, SLU
- Operator Number
- 10061761
- Address
- Carrer del Gall, 22
- City
- Esplugues de Llobregat
- State
- Barcelona
- Postal Code
- 08950
- Country
- ES
- Correspondent
- Claudia Leite
US Agent
- Business Name
- FREYR INC
- Contact Name
- Shilpa Gampa
- Address
- 777 Scudders Mill Road, Building 2, Suite 150
- City
- Plainsboro
- State
- NJ
- ZIP
- 08536
- Country
- US
- [email protected]
- Phone
- 760 5834401
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-11-18 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2025-04-11 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-04-07 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2025-06-11 |
Proprietary Names
Primelase
Preime DermaFacial - MicroT
Preime DermaFacial - VibroX
Preime DermaFacial Collagen+
Elysion Pro
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device