Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010413216

FEI Number

3010413216

Entity Name

SIAM STERI SERVICES CO., LTD

City/State/Country

Panthong Chon Buri, TH

Establishment Address

700/644 Amata Nakorn Industrial Estate, Moo 3 Tambol Bankao, Panthong Chon Buri 20160, TH

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Siam Steri Services Co., Ltd (Owner Number: 10044131)

Owner / Operator Contact Address

700/644 Amata Nakorn Industrial Estate, Moo 3 Tambol Bankao, Panthong, TH-20 20160, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV ADMINISTRATION SET WITH .22 MICRON FILTER IV ADMINISTRATION SET WITH NEEDLELESS ACCESS CONNECTOR IV ADMINISTRATION SET IV ADMINISTRATION SET SECONDARY ADMINISTRATION SET Apheresis Needle Set with MasterGuard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-04-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2019-04-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-04-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2021-12-15
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2019-03-27
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2020-02-10
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2021-12-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2017-06-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-04-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2019-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

Kenneth Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

Siam Steri Services 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010413216. Last updated year: 2026. Please use registration number 3010413216 when referencing this establishment in official correspondence.