Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033588952

FEI Number

3033588952

Entity Name

HOYA Corporation

City/State/Country

Plovdiv, BG

Establishment Address

Vasil Levski str. 179, Plovdiv 4003, BG

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HOYA Corporation PENTAX Division (Owner Number: 8030235)

Owner / Operator Contact Address

3 Paragon Drive, Montvale, NJ 07645, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171011

PMA Number

N/A

All Registered Proprietary Names

VIDEO PROCESSOR (CP-1000) VIDEO NASOPHARYNGOLARYNGOSCOPE (VNL9-CP) Leakage test adapter (OE-B9)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-09-11

Official Correspondent

Paresh Patel

US Agent Details

Paresh Patel Business: HOYA CORPORATION PENTAX DIVISION Email: paresh.patel@pentaxmedical.com Phone: (201) 5712300

Related Public Records

Same Entity

HOYA Corporation PENTAX Division

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012414760	Pentax Medical	Mississauga Ontario, CA
2518897	PENTAX of America, Inc.	MONTVALE, NJ, US
9610877	HOYA Corporation PENTAX Lifecare Division	Akishima-shi Tokyo, JP
3014605202	PENTAX MEDICAL (PENANG) SDN. BHD.	Penang Pulau Pinang, MY
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

Similar Registrations

Registration Number	Establishment Name	Location
3044675089	GRUMPY INNOVATION INC	Sioux Falls, SD, US
1057358	RG Medical USA	Mount Juliet, TN, US
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
3003782610	HOYA Corporation PENTAX Lifecare Division	KURIHARA-SHI Miyagi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033588952. Last updated year: 2026. Please use registration number 3033588952 when referencing this establishment in official correspondence.