Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005921503

FEI Number

3005921503

Entity Name

CHEMEX INDUSTRIAL CO., LTD.

City/State/Country

YUNG KANG Tainan, TW

Establishment Address

23-1, ALLEY 2, LANE 279, CHUNG-CHENG RD., YUNG KANG Tainan 71043, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CHEMEX INDUSTRIAL CO., LTD. (Owner Number: 9098839)

Owner / Operator Contact Address

23, ALLEY 2, LANE 279, CHUNG-CHENG RD.,, YUNG KANG, TW-TNN 71043, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MICROFLOW II Parafree Disposable Base Molds Jet Routine VIII Jet Routine VI Jet Activeflow Biopsy I Activeflow Routine I, Jet Biopsy Vl Jet Routine VII Parafree Metal Base Molds Jet Activeflow II Biopsy HISTOPRO TURBOFLOW II QMICROFLOW II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJI	Specimen/Tissue, Identification Orientation	Pathology	Class 1	864.3010	2018-10-25
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2007-03-09
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2018-10-25
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-12-02
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-02
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-11-17

Official Correspondent

Sandarac Lee

US Agent Details

Patrick O'Neill Business: Cancer Diagnostics Inc. Email: poneill@cancerdiagnostics.com Phone: (877) 8465393

Related Public Records

Same Entity

CHEMEX INDUSTRIAL CO., LTD.

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

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.

Similar Registrations

Registration Number	Establishment Name	Location
1220744	SANDERSON-MACLEOD, INC.	PALMER, MA, US
3008487545	VECTOR SURGICAL, LLC	Menomonee Falls, WI, US
1221051	J-PAC, LLC.	SOMERSWORTH, NH, US
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005921503. Last updated year: 2026. Please use registration number 3005921503 when referencing this establishment in official correspondence.