CHANGZHOU NEWMED MICRO-MEDTECH CO., LTD.

FDA Device Registration & Listing · Changzhou City Jiangsu, CN · Registration 3043141270

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
3043141270
FEI Number
3043141270
Entity Name
CHANGZHOU NEWMED MICRO-MEDTECH CO., LTD.
City/State/Country
Changzhou City Jiangsu, CN
Establishment Address
NO.99 of Longxi Avenue,Zhulin Town,Jintan District,Changzhou City,Jiangsu Province,China, Changzhou City Jiangsu 213241, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Changzhou NewMed Micro-Medtech Co., Ltd. (Owner Number: 10094810)
Owner / Operator Contact Address
NO.99 of Longxi Avenue,Zhulin Town,Jintan District,Changzhou City,Jiangsu Province,China, Changzhou City, CN-JS 213241, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252021
PMA Number
N/A

All Registered Proprietary Names

Disposable Biopsy Forceps Disposable Endoscopic Injection Needles

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2025-12-24
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-12-24

Official Correspondent

Ashe chen chen

US Agent Details

Qihui Zhang Email: Qzhang@Zyppel.Com Phone: (818) 6589168

Related Public Records

Same Entity

Changzhou NewMed Micro-Medtech 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-0020-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023 Hobbs Medical, Inc. 2
Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043141270. Last updated year: 2026. Please use registration number 3043141270 when referencing this establishment in official correspondence.
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