Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044099

FEI Number

3004458261

Entity Name

PACIFIC HOSPITAL SUPPLY CO. LTD.

City/State/Country

TAIPEI, TW

Establishment Address

4 F., NO. 160, DAYE ROAD, BEITOU DISTRICT, TAIPEI 112, TW

Establishment Type(s)

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

Owner / Operator

PACIFIC HOSPITAL SUPPLY CO. LTD. (Owner Number: 9005460)

Owner / Operator Contact Address

4 F., NO. 160, DAYE ROAD, BEITOU DISTRICT, TAIPEI, TW-TPE 112, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

urine meter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-09-10
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2003-03-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2007-03-26
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-09-08
HHI	System, Abortion, Vacuum	Obstetrics/Gynecology	Class 2	884.5070	2008-06-02
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2008-06-02
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	1995-08-16
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2021-03-22
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2006-03-21
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-03-26
HGH	Cannula, Suction, Uterine	Obstetrics/Gynecology	Class 2	884.5070	2008-06-02

Official Correspondent

Tina Chung

US Agent Details

Chi-Feng Chang Business: Qualtech Consulting LLC Email: Chifeng@Qualtechs.Com Phone: (626) 3455899

Related Public Records

Same Entity

PACIFIC HOSPITAL SUPPLY CO. LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014615028	Pacific Hospital Supply Co., Ltd	Tongluo Township Miaoli, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Similar Registrations

Registration Number	Establishment Name	Location
3005574598	MEDTRITION, INC.	Lititz, PA, US
3009247326	Jabil Circuit (Singapore) Pte Ltd	Singapore Central Singapore, SG
9612030	Cardinal Health (Kenmex Medical Specialties)	TIJUANA Baja California, MX
1921846	Cardinal Health	Hazelwood, MO, US
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044099. Last updated year: 2026. Please use registration number 8044099 when referencing this establishment in official correspondence.