Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019798849

FEI Number

3019798849

Entity Name

EXCELLENT MEDICAL TECHNOLOGY (THAILAND) CO., LTD.

City/State/Country

U-Thai District Phra Nakhon Si Ayutthaya, TH

Establishment Address

1) 66 Moo 1, Banchang Sub-district, 2) 42/20 Moo 4 U-thai Sub-district, U-Thai District Phra Nakhon Si Ayutthaya 13210, TH

Establishment Type(s)

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

Owner / Operator

Excellent Medical Technology (Thailand) Co., Ltd. (Owner Number: 10082072)

Owner / Operator Contact Address

66 Moo 1, Banchang Sub-district, U-Thai District, TH-14 13210, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Kits Surgical Drape, equipment cover, operation drape BANDAGE Inflateable Transfer Sheet; Airsling Urine bags; Urine collection Bags; Urine collection system BEDDING Patient Transfer sheet, Inflatable sheet, AIR SHEET,COMFORT GLIDE, Repositioning Sheet, Lateral Transfer Sheet Gauze ABD Pads Surgical Magnet Drape, Surgical Instrument Holder Drape, Instrument Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-06-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-06-11
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2026-03-12
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2025-11-27
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-12-24
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2025-09-01
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-06-11
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2024-05-13
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-06-11
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-12-14
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-11-27
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2025-07-27
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2025-11-28
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-07-10
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2025-09-01
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-08-20

Official Correspondent

Kenney SONG

US Agent Details

ZHENG XU Email: cathygeng2007@gmail.com Phone: (248) 5508758

Related Public Records

Same Entity

Excellent Medical Technology (Thailand) 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Similar Registrations

Registration Number	Establishment Name	Location
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3004133257	AMMAR APPAREL II S. DE R.L DE C.V.	CALKINI Campeche, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3030626857	PALM MEDICAL INTERNATIONAL BV	Buggenhout Oost-Vlaanderen, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019798849. Last updated year: 2026. Please use registration number 3019798849 when referencing this establishment in official correspondence.