Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017113900

FEI Number

3017113900

Entity Name

STERIVIC MEDICAL CO.,LTD.

City/State/Country

ChiZhou Anhui, CN

Establishment Address

DaDuKou Economic Development Zone, ChiZhou Anhui 247210, CN

Establishment Type(s)

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

Owner / Operator

Sterivic Medical Co.,Ltd. (Owner Number: 10095456)

Owner / Operator Contact Address

DaDuKou Economic Development Zone, ChiZhou, CN-AH 247210, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251347

PMA Number

N/A

All Registered Proprietary Names

Sterilization Pouch/Roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2026-03-15
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2026-03-15

Official Correspondent

Coy Gui

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Sterivic 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 3017113900. Last updated year: 2026. Please use registration number 3017113900 when referencing this establishment in official correspondence.