Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096058

FEI Number

3016096058

Entity Name

INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED

City/State/Country

Dong Mai Ward Quang Ninh, VN

Establishment Address

LOT CN-03, Dong Mai Industrial Park,, Dong Mai Ward Quang Ninh 01000, VN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED (Owner Number: 10061749)

Owner / Operator Contact Address

LOT CN-03, Dong Mai Industrial Park,, Dong Mai Ward, VN-13 01000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053254

PMA Number

N/A

All Registered Proprietary Names

Overbed Table Polyethylene Gowns,Non-surgical heat patch Electrode TENS Electrode PACK, HOT OR COLD, DISPOSABLE Infant heel warmer (chemical heat pack)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2025-06-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-03-17
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2025-08-11
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2023-05-30
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2019-11-15
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	Class 1	890.5710	2019-11-15

Official Correspondent

Max Li

US Agent Details

Max Lee Business: Primemax Email: maxli@basicmedical.com Phone: (909) 9801678

Related Public Records

Same Entity

INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
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
9615415	PRIME PACIFIC HEALTH INNOVATIONS CORPORATION	PORT COQUITLAM British Columbia, CA
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
1063324	REACT Innovations	Charlotte, NC, US
3043460907	Drive DeVilbiss Healthcare	Perris, CA, US
3005214422	HOMECARE ENTERPRISE CO., LTD.	Changhua City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096058. Last updated year: 2026. Please use registration number 3016096058 when referencing this establishment in official correspondence.