Chengdu Daxan Innovative Medical Tech. Co., Ltd.

FDA Device Registration & Listing · chengdu Sichuan, CN · Registration 3023329815

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
3023329815
FEI Number
3023329815
Entity Name
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
City/State/Country
chengdu Sichuan, CN
Establishment Address
East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District, chengdu Sichuan 611137, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Chengdu Daxan Innovative Medical Tech. Co., Ltd. (Owner Number: 10086949)
Owner / Operator Contact Address
East side of distribution Center 3,No.566,West Section of Kexing Road, Wenjiang District, Chengdu, CN-SC 611137, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Disposable Intermittent Catheter (TPU Catheter)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2026-06-03

Official Correspondent

Huang Wei

US Agent Details

Sarah Galemmo Business: ICAS Biologics Co.Ltd. Email: US.agent@icas.org.cn Phone: (661) 8033155

Related Public Records

Same Entity

Chengdu Daxan Innovative Medical Tech. 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-0004-2013 Cure Medical LLC 2
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023329815. Last updated year: 2026. Please use registration number 3023329815 when referencing this establishment in official correspondence.
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