FDA Registration
Active
🇪🇸 Spain
INDIBA
Reg #: 3010836847
·
FEI: 3010836847
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- INDIBA
- Registration Number
- 3010836847
- FEI Number
- 3010836847
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Moianes, 13
- City
- Sant Quirze del Valles Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K243164
Owner / Operator
- Firm Name
- INDIBA S.A.U.
- Operator Number
- 10053645
- Address
- Moianes, 13
- City
- Sant Quirze del Valles
- State
- Barcelona
- Postal Code
- 08192
- Country
- ES
- Correspondent
- Nieves Arias
US Agent
- Business Name
- K-LASER USA Inc
- Contact Name
- Remco Schmitz
- Address
- 345 Inverness Dr S Bldg B
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
- [email protected]
- Phone
- 617 4559838
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2024-12-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-05-23 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2017-01-24 |
Proprietary Names
INDIBA
INDIBA, S.A.U.
Indiba Optimum Cream
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device