Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009470597

FEI Number

3009470597

Entity Name

FOAMTEC INTERNATIONAL CO., LTD.

City/State/Country

Sriracha Chon Buri, TH

Establishment Address

Laemchabang Industrial Estate, Export Processing, 259/1 Moo 3, Toongsukhla, Sriracha Chon Buri 20230, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Foamtec International Co., Ltd. (Owner Number: 10040498)

Owner / Operator Contact Address

Laemchabang Industrial Estate, Export Processing, 259/1 Moo 3, Toongsukhla, Sriracha, TH-20 20230, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tampon, Menstrual, Unscented - Livi Device, MP501-LIV Endoscope Cleaners Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5304I-SY; MP5305I-SY; MP5306I-SY; MP5307I-SY; MP5308I-SY Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5406I-SY; MP5407I-SY; MP5408I-SY; MP5409I-SY Swicker Mitt Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5501I-SY Swicker Digit Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5500I-SY Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5309I-SY; MP5401I-SY; MP5402I-SY; MP5404I-SY; MP5405I-SY Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5207I-SY; MP5208I-SY; MP5209I-SY; MP5301I-SY; MP5302I-SY Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5202I-SY; MP5302I-SY; MP5402I-SY Swicker Z100SORB with Radiopaque Ink Dots Non-Sterile, MP5201I-SY; MP5202I-SY; MP5204I-SY; MP5205I-SY; MP5206I-SY NON081144NC, Adult Head Positioner; NON081147, Comfort Touch Head Positioner HT4029-MD, Head Positioner, Ring7"; HT4032-MD, Slotted Foam Head Positioner NON081340, Ulnar Nerve Cushion; NON081343, Foam Arm Board Pads; NON081344NC, Arm Cradle NON081440, Heel Protector; NON081448, Abduction Pillow, Small NON081449, Abduction Pillow, Medium; NON081450, Abduction Pillow, Large HT4034-MD, Multi Ring Head Positioner; HT4035-MD, Foam Arm Board Pads; HT4036-MD, Arm Cradle NON081244, Foam Positioning Wedge; NON081245, Disposable Foam Wedge NON081141, Head Positioner, Ring 9"; NON081142, Head Positioner, Ring 7", NON081143, Slotted Foam Head Positioner HT4055-MD, OR Eggcrate Pad; HT4066-MD, Abduction Pillow, Small; HT4067-MD, Abduction Pillow, Medium HT4037-MD, Adult Head Positioner; HT4042-MD, Disposable Foam Wedge; HT4051-MD, Foam Positioning Wedge HT4052-MD, Medicine Cup Holder; HT4054-MD, Head Positioner 103049, OR Eggcrate Pad; 103115, Head Positioner; 103496, Medicine Cup Holder; HT4028-MD, Comfort Touch Head Positioner HT4068-MD, Abduction Pillow, Large; NON081140, Multi Ring Head Positioner Swab Applicator, Arrow Tip Swab, HT1321; Swab Applicator, Arrow Tip Swab, HT1320 Swab Applicator, Round Swab, HT1319; Swab Applicator, Round Swab, HT1318 DT3542, Dragontail, Microfiber Endoscopic Channel Brush DT2022, Dragontail, Microfiber Endoscopic Channel Brush; DT2832, Dragontail, Microfiber Endoscopic Channel Brush; Sterile CleanWIPE® Small Tip Foam Swab, MP1301AST Sterile CleanWIPE® Medium Tip Foam Swab, MP1302ET-12; MP1302ET-20; MP1302ET-2000; MP1302SE2 Sterile CleanWIPE® Medium Flexible Tip Foam Swab, MP1303ST; MP1303ET; MP1314SE; MP1309ST SOFTouchTM, General and Oropharyngeal Swab, Regular Foam Tip, Rigid Shaft, Specimen Collection Swab, MP1202ST-HAR Sterile CleanFOAM Diagnotic, MP1304ST; MP1306ST SOFTouchTM, Nasopharyngeal Swab, Mini Foam Tip, Flexible Shaft, Specimen Collection Swab, MP1201ST-HAR Sterile CleanWIPE® Medium Tip Foam Swab, MP1302ST; MP1302ST-12; MP1302ST-20; MP1302ST-2000; MP1308ST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2026-04-23
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-12-12
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2022-05-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2012-11-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2018-12-12
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2015-07-09
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-18

Official Correspondent

Thng Cheok Long

US Agent Details

Michael Strauss Business: Foamtec International, LLC Email: mstrauss@foamtecusa.com Phone: (254) 7088137

Related Public Records

Same Entity

Foamtec International 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
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02
K930149	Kimberly-Clark Corp.	KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+	1994-03-02
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009470597. Last updated year: 2026. Please use registration number 3009470597 when referencing this establishment in official correspondence.