Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000175697

FEI Number

1000175697

Entity Name

HARITEX CORPORATION

City/State/Country

TAIPEI CITY, TW

Establishment Address

ROOM. 705, 7th FLOOR, ASIA BUSINESS CENTER, NO. 1, FUHSING NORTH ROAD, TAIPEI CITY 10595, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HARITEX CORPORATION (Owner Number: 9020042)

Owner / Operator Contact Address

RM. 705, ASIA BUSINESS CTR, NO. 1,, FUHSING NORTH ROAD,, TAIPEI CITY, TW-TPE 10595, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VARIOUS TYPES OF GENERAL AND PLASTIC SURGERY STAPLE REMOVERS(SKIN). VARIOUS TYPES OF ICE BAGS VARIOUS TYPES OF DISPOSABLE MEDICAL SCISSORS. HEMOSTAT VARIOUS TYPES OF GENERAL AND PLASTIC SURGERY FORCEPS. MEDLINE- GENERAL AND PLASTIC SURGERY FORCEPS. HEMOSTATIC CLIP MEDLINE SCISSORS, GENERAL, SURGICAL-LRW

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2004-11-04
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2003-09-12
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1995-04-28
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2023-06-08
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1995-04-28
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2023-05-12
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-09-27

Official Correspondent

Lillian WU

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

HARITEX CORPORATION

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-05	N/A	1	Hem-o-lok Endo5 Ligation Applier

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1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US
3006210673	ZHEJIANG MEDIUNION HEALTHCARE GROUP CO.,LTD	Ningbo Zhejiang, CN
3016994953	CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO., LTD.	Changzhou Jiangsu, CN
3011137372	Teleflex Medical LLC	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000175697. Last updated year: 2026. Please use registration number 1000175697 when referencing this establishment in official correspondence.