Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007663056

FEI Number

3007663056

Entity Name

SHANGHAI HUIHU MEDICAL APPLIANCE CO. LTD.

City/State/Country

Shanghai, CN

Establishment Address

118 Lin Dong Road, Qing Cun Town, Feng Xian District, Shanghai 201414, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Huihu Medical Appliance Co. Ltd. (Owner Number: 10029468)

Owner / Operator Contact Address

118 Lin Dong Road, Qing Cun Town, Feng Xidan District, Shanghai, CN-SH 201414, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Absorbent Mat Mop Heads Tray Corner Protector Nasotracheal Tube Immobilizer Suture Bag Emesis Bag Dispenser Basin Emesis Bag Bowls Plastic Cup Needle Counters Plastic Holder Syringe Bulb Syringe Kit Accessories Foot Pedal Bag Scalpel Handle Shoulder Suspension Kit Foam Positioning Products to include Head Rests, body positioners, and covers Skin Markers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2011-08-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2011-04-12
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2011-02-11
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-05-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2011-04-12
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2011-04-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2011-08-09
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2011-08-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2011-04-12
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2009-05-18

Official Correspondent

Chen Ye

US Agent Details

Paul Lloyd Business: XODUS MEDICAL INC Email: plloyd@xodusmedical.com Phone: (724) 3375500

Related Public Records

Same Entity

Shanghai Huihu Medical Appliance 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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007663056. Last updated year: 2026. Please use registration number 3007663056 when referencing this establishment in official correspondence.