Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042896810

FEI Number

3042896810

Entity Name

Jenius Medical Sci-Tech (Thailand) Co., Ltd.

City/State/Country

Nong Yai District, Chon Buri, TH

Establishment Address

868-2 Moo 6, Nong Yai Subdistrict,, Nong Yai District, Chon Buri 20190, TH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Jenius Medical Sci-Tech (Thailand) Co., Ltd. (Owner Number: 10094893)

Owner / Operator Contact Address

868-2 Moo 6, Nong Yai Subdistrict,, Nong Yai District, TH-20 20190, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Isolation/Surgical Suit Drape Urological Bandage Sterile Eye Wash Normal Saline Safety Pin Non-Adherent Pad and Dressing Exercise Non-Measuring Cotton Tip Applicators/Cotton Swabs Cotton Wool Ball/Cotton Ball Oxygen Mask CPR Face Shield Mask Bite Block Tongue Depressor Water Bottle Water Cup Cleaning Wipe First Aid Kit Face Mask Gloves Examination Patient TPE Cover Surgical Cap Disposable Mask Flashlight Tweezers/Forceps Non-Woven Tape/Medical Tape/First Aid Roll Adhesive Bandage/Adhesive Strips/ Fabric

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2026-01-03
EYY	Drape, Urological, Disposable	General, Plastic Surgery	Class 2	878.4370	2026-01-03
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2026-01-03
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2026-01-03
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2026-01-03
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	Class 1	890.5370	2026-01-03
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2026-01-03
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2026-01-03
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2026-01-03
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2026-01-03
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2026-01-03
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2026-01-03
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2026-01-03
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2026-01-03
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2026-01-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2026-01-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-01-03

Official Correspondent

No official correspondent registered.

US Agent Details

William Slevin Business: Medapproval LLC Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

Jenius Medical Sci-Tech (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
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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042896810. Last updated year: 2026. Please use registration number 3042896810 when referencing this establishment in official correspondence.