Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008132392

FEI Number

3008132392

Entity Name

Medicom Asia-Pacific Holdings Limited. Taiwan Branch

City/State/Country

Wujie Township Yilan, TW

Establishment Address

No.11, Sec2, Ligong 1st Rd, Wujie Township Yilan 26841, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medicom Group (Owner Number: 9007111)

Owner / Operator Contact Address

2555 Chemin De L Aviation, Pointe Claire, CA-QC H9P 2Z2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medicom Sterilization Pouches & Reels Pouches & Reels Medicom SafeBasics Medicom SafeMask Medicom AssureMask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2001-01-30
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-04-09
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-04-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	1996-05-01

Official Correspondent

No official correspondent registered.

US Agent Details

Brent Geiger Business: United Medical Enterprise Email: bgeiger@medicom.com Phone: (763) 2189292

Related Public Records

Same Entity

Medicom Group

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003230618	AR MEDICOM INC., (ASIA), LTD.	Hongkong Hong Kong, CN
3017425988	AMD MEDICOM INC.	Saint-Laurent Quebec, CA
3017949824	United Medical Enterprise, Inc.	Thomson, GA, US
3006691703	A.R. Medicom Inc. (Shanghai) Co., Ltd.	Shanghai, CN
3036622014	Medicom Healthcare (Thailand) Co., Ltd.	Tambol Nong Yai Chon Buri, TH

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-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008132392. Last updated year: 2026. Please use registration number 3008132392 when referencing this establishment in official correspondence.