FDA Registration
Active
🇯🇵 Japan
VIDEO GASTROSCOPE (EG-290KP-OUS)
Reg #: 3003782610
·
FEI: 3003782610
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
2
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 |
|---|---|---|---|---|---|
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2017-10-17 |
Proprietary Names
VIDEO GASTROSCOPE (EG-290KP-OUS)
FIBEROPTIC GASTROSCOPE (FG-24V-OUS)
ADAPTER, WATER JET CHECK-VALVE UNIT FOR 30 (OF-B119)
VIDEO SMALL BOWEL ENTEROSCOPE (VSB-2990I-OUS)
FIBEROPTIC GASTROSCOPE (FG-29V-OUS)
DISTAL RUBBER HOOD FOR EG-2990ZI (OE-A58)
CARRYING CASE (VE-G17)
VIDEO GASTROSCOPE (EG27-V10C-OUS)
VIDEO GASTROSCOPE (EG-2990Zi-OUS)
VIDEO GASTROSCOPE (EG16-K10-OUS)
VIDEO GASTROSCOPE (EG29-V10C-OUS)
IMAGINA STANDARD HD GASTROSCOPE (EG29-I10C)
VIDEO GASTROSCOPE (EG17-J10)
Light Guide Plug Cap (OE-C23-OUS)
PENTAX MEDICAL VIDEO UPPER GI SCOPE EG29-i20c
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device