FDA Registration
Active
🇧🇬 Bulgaria
VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP)
Reg #: 3033588952
·
FEI: 3033588952
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation
- Registration Number
- 3033588952
- FEI Number
- 3033588952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Vasil Levski str. 179
- City
- Plovdiv
- Country
- BG
Regulatory Submissions
- 510(k) Number
- K171011
Owner / Operator
- Firm Name
- HOYA Corporation PENTAX Division
- Operator Number
- 8030235
- Address
- 3 Paragon Drive
- City
- Montvale
- State
- NJ
- Postal Code
- 07645
- Country
- US
- Correspondent
- Gurvinder Nanda
US Agent
- Business Name
- HOYA CORPORATION PENTAX DIVISION
- Contact Name
- Gurvinder Nanda
- Address
- 3 Paragon Dr
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2018-09-11 |
Proprietary Names
VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP)
VIDEO PROCESSOR (CP-1000)
Leakage test adapter (OE-B9)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device