FDA Registration
Inactive
🇷🇴 Romania
HOBIAN S.R.L.
·
Expires 2026
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- HOBIAN S.R.L.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Drumul Gura Calitei, Nr. 17B, Ground floor, Apt. 4, District 3
- City
- Bucharest Bucuresti
- Country
- RO
Regulatory Submissions
- 510(k) Number
- K181497
Owner / Operator
- Firm Name
- HOBIAN S.R.L.
- Operator Number
- 10095991
- Address
- Drumul Gura Calitei, Nr. 17B, Ground floor, Apt. 4, District 3
- City
- Bucharest
- State
- Bucuresti
- Postal Code
- 032604
- Country
- RO
- Correspondent
- Catalin Sirbu
US Agent
- Business Name
- BTL Industries Inc.
- Contact Name
- David Chmel
- Address
- 362 Elm St
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 866 2851656 ext. 202
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2026-06-04 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-06-04 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2026-06-04 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2026-06-04 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2026-06-04 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2026-06-04 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device