JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD.

FDA Device Registration & Listing · Jiangmen Guangdong, CN · Registration 3035856230

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035856230
FEI Number
3035856230
Entity Name
JIANGMEN NEW ERA EXTERNAL DRUG USE CO., LTD.
City/State/Country
Jiangmen Guangdong, CN
Establishment Address
No.8 Beiyuan Rd, Jianghai District, Jiangmen Guangdong 529000, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Jiangmen New Era External Drug Use Co., Ltd. (Owner Number: 10092452)
Owner / Operator Contact Address
No.8 Beiyuan Rd, Jianghai District, Jiangmen, CN-GD 529000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241036
PMA Number
N/A

All Registered Proprietary Names

Autoclave Indicator Tape; EO Indicator Tape

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 2025-01-09

Official Correspondent

Yingxuan Mu

US Agent Details

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

Related Public Records

Same Entity

Jiangmen New Era External Drug Use 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 3035856230. Last updated year: 2026. Please use registration number 3035856230 when referencing this establishment in official correspondence.
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