Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038280948

FEI Number

3038280948

Entity Name

MEDWELL CO.,LTD.

City/State/Country

Gateway Chachoengsao, TH

Establishment Address

176/1 Moo 7 Soi 7, Gateway City Rd.,Huasomrong, Plaengyao, Chachoengsao 24190, Gateway Chachoengsao 24190, TH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medwell CO.,LTD. (Owner Number: 10093395)

Owner / Operator Contact Address

176/1 Moo 7 Soi 7, Gateway City Rd.,Huasomrong, Plaengyao, Chachoengsao 24190, Gateway, TH-24 24190, TH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US Behind-the-Ear Hearing Aid, model: HTD6102US Non-Contact 3-in-1 Thermometer Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A Electric Nasal Aspirator, Model: HTD2601US, HTD2602US, H2603US, H2605US, H2606US, H2609AU, H2609US Infrared Body Thermometer,Model:HTD8220US Postpartum Catch-All Pads, Model: K5501US; Postpartum Pads, Model: K5502US Electronic Blood Pressure Monitor,D6606US,D6607US Instant Ice Maxi Pads, Postpartum Ice Pack Pads, Model: K5201US, K5202US Upside Down Peri Bottle, Model: K5101US; Peri Bottle, Model: K5102US

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-12
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2025-06-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-12
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-06-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-05-12
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2025-05-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-05-12
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-05-12
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2025-05-12

Official Correspondent

Tom Chen

US Agent Details

Hui Hong Business: ABMED SERVICE INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Medwell 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
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
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038280948. Last updated year: 2026. Please use registration number 3038280948 when referencing this establishment in official correspondence.