FDA Registration
Active
🇯🇵 Japan
VIDEO PROCESSOR (EPK-3000-OUS)
Reg #: 3003782610
·
FEI: 3003782610
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation PENTAX Lifecare Division
- Registration Number
- 3003782610
- FEI Number
- 3003782610
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30-2 Okada, Aza-Shimomiyano, Tsukidate
- City
- KURIHARA-SHI Miyagi
- Country
- JP
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 Drive
- City
- Montvale
- State
- NJ
- ZIP
- 07645
- Country
- US
- [email protected]
- Phone
- 201 5712318
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | Class 2 | Gastroenterology, Urology | No | 2017-10-17 |
Proprietary Names
VIDEO PROCESSOR (EPK-3000-OUS)
VIDEO PROCESSOR - (EPK-V1500C-OUS)
WATER BOTTLE ASSEMBLY AUTOCLAVABLE (OS-H4)
VIDEO PROCESSOR - INTERNATIONAL (EPK-I7010-OUS)
VIDEO PROCESSOR - (EPK-I5010-OUS)
VIDEO PROCESSOR, (EPK-i5500c-OUS)
IMAGINA I-SCAN SOFTWARE KEY (OS-I14)
PENTAX MEDICAL VIDEO PROCESSOR (EPK-i8020c)
PENTAX Medical EXIF Viewer (OS-I20)
PENTAX Medical Keyboard EN (OS-A115)
PENTAX White Balance Adjuster (OS-A43)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device