Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021361802

FEI Number

3021361802

Entity Name

STERILERIGHT PACKAGING MFG INC.

City/State/Country

Keelung, TW

Establishment Address

1F, No. 33-7, Dahua 2nd RD., Qidu Dist., Keelung 20653, Taiwan, Keelung 20653, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sterileright Packaging Mfg Inc. (Owner Number: 10083625)

Owner / Operator Contact Address

1F, No. 33-7, Dahua 2nd RD., Qidu Dist., Keelung 20653, Taiwan, Keelung, TW-KEE 20653, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212338

PMA Number

N/A

All Registered Proprietary Names

Sterileright

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2021-12-07
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-12-07

Official Correspondent

Laney Huang

US Agent Details

Julia Huang Email: julia.huang@gmaxind.com Phone: (631) 9531268

Related Public Records

Same Entity

Sterileright Packaging Mfg Inc.

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 3021361802. Last updated year: 2026. Please use registration number 3021361802 when referencing this establishment in official correspondence.