Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038283966

FEI Number

3038283966

Entity Name

L WELL MEDTECH SOLUTIONS SDN. BHD.

City/State/Country

Nibong Tebal Pulau Pinang, MY

Establishment Address

1729 Lorong Industri Satu Kawasan Industri Bukit Panchor, Nibong Tebal Pulau Pinang 14300, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

L WELL MEDTECH SOLUTIONS SDN. BHD. (Owner Number: 10093356)

Owner / Operator Contact Address

1729 Lorong Industri Satu Kawasan Industri Bukit Panchor, Nibong Tebal, MY-07 14300, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPLINT SCISSORS, MEDICAL, DISPOSABLE TAPE SCISSORS BANDAGE SCISSORS Kinesiology tape Muscle Tape TAPE, REGULAR, RIGID, PERFORATED, WATERPROOF, SPORT TAPE WOUND DRESSING, HOCKEY, PE, NON-WOVEN, SAW SILK. OXIDE TAPE Kinesio Tape BANDAGE, CAST POLYMER AND FIBERGLASS CASTING BANDAGE Gsport First Aid Kit First Aid Kit Gspcare First Aid Kit Gspmed First Aid Kit GAUZE AND RUBBER BANDAGE LATEX AND LATEX FREE NON-WOVEN ELASTIC CREPE & PLAIN, CONFORMING (PET), COLD, FOAM COHESIVE ELASTIC, SOFT BAN PADDING, POP, CO-GAUZE LATEX FREE COTTON POWERRIP PACK, HOT OR COLD, DISPOSABLE INSTANT COLD AND HOT PACK Liquid Bandage Plaster Spray BANDAGE, LIQUID, SKIN PROTECTANT Liquid Bandage Spray Gspmed Alcohol Pad Alcohol Pad Gsport Alcohol pad Gspcare Alcohol pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYH	Splint, Extremity, Noninflatable, External, Sterile	General, Plastic Surgery	Class 1	878.3910	2025-05-05
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2025-05-05
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-05-05
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2025-05-05
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2025-05-05
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-05-05
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-05-05
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2025-05-05
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-05-05

Official Correspondent

Jing Chen

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

L WELL MEDTECH SOLUTIONS SDN. BHD.

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
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
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3022381831	THETIS MEDICAL LTD.	Godalming Surrey, GB
3023917	ACME UNITED CORP.	VANCOUVER, WA, US
9616933	I-MING SANITARY MATERIALS CO., LTD.	Changhua, TW
3006621348	CHANGZHOU MAJOR MEDICAL PRODUCTS CO., LTD.	CHANGZHOU Jiangsu, CN
1926174	Brownmed	Spirit Lake, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038283966. Last updated year: 2026. Please use registration number 3038283966 when referencing this establishment in official correspondence.