Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011495142

FEI Number

3011495142

Entity Name

TONGXIANG BAO-HEALTH MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Tongxiang Zhejiang, CN

Establishment Address

Bldg. 22-23, No 869 Fengxiang East Road, Tongxiang Zhejiang 314500, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tongxiang BAO-Health Medical Instrument Co., Ltd. (Owner Number: 10047897)

Owner / Operator Contact Address

Bldg. 22-23, No 869 Fengxiang East Road, Tongxiang, CN-ZJ 314500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ostomy bag Urostomy bag Bend Scissors TWO PC OPEN POUCH TWO-PC CLOSED POUCH PROTECTIVE RING/STRIP STOMA PASTE ADHESIVE REMOVER SKIN BARRIER SUPPORT SKIN PROTECTIVE FILM STOMA BELT ONE PIECE DRAINABLE POUCH OSTOMY BAG Flange for two pc pouch one piece drainable pouch one-pc closed pouch TWO-PC CLASSICAL POUCH (CLAMP CLOSURE) Colostomy bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2014-11-13
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2020-02-17
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-06-05
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-06-05
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-06-04
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	2015-06-05
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2015-06-04
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2014-11-13

Official Correspondent

Nancy Wang

US Agent Details

James H. Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Tongxiang BAO-Health Medical Instrument 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-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

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2320961	HOLLISTER, INC.	Mount Juliet, TN, US
2183564	ADDEV Materials Healthcare	Menomonee Falls, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011495142. Last updated year: 2026. Please use registration number 3011495142 when referencing this establishment in official correspondence.