Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003624296

FEI Number

3003624296

Entity Name

HOGY MEDICAL CO., LTD.

City/State/Country

INASHIKI-GUN Ibaraki, JP

Establishment Address

MIHO NO.1 PLANT, 1873-1 FUSA, MIHO-MURA, INASHIKI-GUN Ibaraki 300-0427, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HOGY MEDICAL CO., LTD. (Owner Number: 9052264)

Owner / Operator Contact Address

1650-30 Okubara-Cho, Ushiku, Ibaraki, JP-NOTA 300-1283, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STERRAD SEALSURE Chemical Indicator Tape STERRAD SEALSURE Chemical Indicator Tape (Non-Latex 14202NL)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2013-02-11
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2024-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Brent Lewis Email: brent.lewis@asp.com Phone: (949) 5619525

Related Public Records

Same Entity

HOGY MEDICAL CO., LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003624296. Last updated year: 2026. Please use registration number 3003624296 when referencing this establishment in official correspondence.