Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012454004

FEI Number

3012454004

Entity Name

HANGZHOU SUNING MEDICAL CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

T4-1004, EFC American Center, Cangqian District, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HANGZHOU SUNING MEDICAL CO.,LTD (Owner Number: 10051840)

Owner / Operator Contact Address

T4-1004, EFC American Center, Cangqian District, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation Gown Table Strap Wedge Pad Disposable Linen; Underpad Convenient Kit (Underpad, Lift Sheet, Bag, Mop, Strap) Nonwoven Head Positioner Cover Head Covers Nonwoven Protector Nonwoven Armboard Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2016-05-09
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-05-09
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2016-05-09

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

HANGZHOU SUNING MEDICAL CO.,LTD

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012454004. Last updated year: 2026. Please use registration number 3012454004 when referencing this establishment in official correspondence.