Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008530360

FEI Number

3008530360

Entity Name

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 488-1, North Donghu Road, Linping District, Hangzhou Zhejiang 311199, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd. (Owner Number: 10055959)

Owner / Operator Contact Address

No. 488-1, North Donghu Road, Linping District, Hangzhou, CN-ZJ 311199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Amalgamator; VOCO GIC Mixer DOLORCLAST Focused Shock Waves

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2017-10-22
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	General, Plastic Surgery	Class 2	878.4685	2025-08-29

Official Correspondent

Teresa Chen

US Agent Details

Stephen Lieberman Lieberman Email: Liebs4545@Gmail.com Phone: (561) 7509949

Related Public Records

Same Entity

E.M.S. Electro Medical Systems (Hangzhou) Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1216602	LANTHEUS MEDICAL IMAGING, Inc.	N Billerica, MA, US
3001065024	RENFERT GMBH	HILZINGEN Baden-Wurttemberg, DE
1410097	GC AMERICA INC.	ALSIP, IL, US
9612300	GC CORP.	ITABASHI-KU Tokyo, JP
3035693034	Solventum Germany GmbH	Kist Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008530360. Last updated year: 2026. Please use registration number 3008530360 when referencing this establishment in official correspondence.