Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019373845

FEI Number

3019373845

Entity Name

CHANGZHOU EMANMED BIOTECHNOLOGY CO., LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.558, Changshun Road, Wujin Economical Development Zone, Changzhou Jiangsu 213161, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Changzhou Emanmed Biotechnology Co., Ltd (Owner Number: 10081787)

Owner / Operator Contact Address

No.558, Changshun Road, Wujin Economical Development Zone, Changzhou, CN-JS 213161, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Balloon Inflation Device STIMULATOR, NERVE Needle Counter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2023-08-28
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2026-03-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-09-25

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Changzhou Emanmed Biotechnology Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10
K150005	Ndi Medical, LLC	Checkpoint, Checkpoint Head & Neck	2015-02-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3016931787	BRUN MEDICAL CO., LTD.	Zhuzhou Hunan, CN
3018182863	SUZUYO CO., LTD	Yokohama Kanagawa, JP
1921846	Cardinal Health	Hazelwood, MO, US
3007361214	SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.	Shenzhen Guangdong, CN
3006223010	GENOSS Co., Ltd.	Suwon-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019373845. Last updated year: 2026. Please use registration number 3019373845 when referencing this establishment in official correspondence.