Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004970050

FEI Number

3004970050

Entity Name

SIGMA MEDICAL SUPPLIES CORP.

City/State/Country

Gueishan Taoyuan, TW

Establishment Address

29 Jianguo E.Rd., Gueishan Taoyuan 33341, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SIGMA MEDICAL SUPPLIES CORP. (Owner Number: 9026902)

Owner / Operator Contact Address

29 Jianguo E.Rd., Gueishan, TW-TAO 33341, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180661

PMA Number

N/A

All Registered Proprietary Names

Sterilization Pouch/Roll Made with Tyvek SIGMA Sterilization Pouch and Roll

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	2018-06-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-06-12
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2018-06-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2018-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SIGMA MEDICAL SUPPLIES CORP.

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.

Similar Registrations

Registration Number	Establishment Name	Location
3007412809	STERIS Corporation	FRANKLIN PARK, IL, US
2410251	PROPPER MFG. CO., INC.	Long Island City, NY, US
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004970050. Last updated year: 2026. Please use registration number 3004970050 when referencing this establishment in official correspondence.