FDA Registration
Active
🇯🇵 Japan
ADAPTER, TCH SCOPE, PENTAX TO SCOPE W/RIGID OCULAR (AT-UR2)
Reg #: 9610877
·
FEI: 3008185830
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HOYA Corporation PENTAX Lifecare Division
- Registration Number
- 9610877
- FEI Number
- 3008185830
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tsutsujigaoka 1-1-110
- City
- Akishima-shi Tokyo
- 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 |
|---|---|---|---|---|---|
| Attachment, Teaching, For Endoscope | FEA | Class 1 | Gastroenterology, Urology | No | 2007-06-29 |
Proprietary Names
ADAPTER, TCH SCOPE, PENTAX TO SCOPE W/RIGID OCULAR (AT-UR2)
ADAPTER,TCH SCOPE, RIGID TO PENTAX SCOPE (AT-ST2)
VIDEO ADAPTER MODULE EPK W/OUT EYEPIECE (PVK-1070Z)
F16-34 Zoom Coupler (S_413024)
VIVIDEO CAMERA COUPLER (S_081-006)
VIVIDEO CAMERA (PVK-CP)
SINGLE ROUND TRIP CARRYING CASE, PVK (VE-VA6)
CAMERA HEAD (PVK-J10)
ADAPTER, EYEPIECE/RIGID OCULAR (AP-RV3)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility