FDA Registration
Active
🇧🇬 Bulgaria
SCHOELLY-OPTIX OOD
Reg #: 3014644276
·
FEI: 3006149253
·
Expires 2026
Products
17
Proprietary Names
14
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- SCHOELLY-OPTIX OOD
- Registration Number
- 3014644276
- FEI Number
- 3006149253
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Krastyo Geshanov 30
- City
- Panagyurishte Pazardzhik
- Country
- BG
Owner / Operator
- Firm Name
- SCHOELLY FIBEROPTIC, GMBH
- Operator Number
- 9004385
- Address
- ROBERT-BOSCH-STR. 1-3, --
- City
- DENZLINGEN
- State
- DE-NOTA
- Postal Code
- 79211
- Country
- DE
- Correspondent
- GERHARD - HERBSTRITT
US Agent
- Business Name
- SCHOELLY USA Inc.
- Contact Name
- James Bonneville
- Address
- 360 Church St., Suite 130
- City
- Northborough
- State
- MA
- ZIP
- 01532
- Country
- US
- [email protected]
- Phone
- 508 9268855
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2015-11-10 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2014-08-19 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2014-10-15 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2023-06-06 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-06-06 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2023-06-06 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2023-06-06 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2013-03-08 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2013-03-08 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2008-03-10 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2016-02-11 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2016-02-11 |
| Obturator, For Endoscope | FEC | Class 2 | Gastroenterology, Urology | No | 2016-02-11 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2015-03-12 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2015-03-12 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2011-01-27 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2016-07-28 |
Proprietary Names
LED Light Sources
Arthroscopes
Endoscopic Camera Control Unit
NIR FI Light Source
Endoscopic Camera Heads
2D NIR FI Laparoscopes
Uretero-Renoscope
Sealing caps
Three slot membrane
Laparoscopes
Hysteroscopes
Cystoscopes
Light guides
Sinuscopes
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)