Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064619

FEI Number

3003063145

Entity Name

GLOBAL-TEC ENTERPRISES, INC.

City/State/Country

Eatonton, GA, US

Establishment Address

939 Greensboro Road, Eatonton, GA 31024, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GLOBAL-TEC ENTERPRISES, INC. (Owner Number: 9042213)

Owner / Operator Contact Address

939 Lake Oconee Parkway, Eatonton, GA 31024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tribest Jiangyin Jiangyin Jiangyin Tribest

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2013-01-31
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2019-01-29
DZM	Needle, Dental	Dental	Class 1	872.4730	2018-08-12
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-24

Official Correspondent

ADRIANA VELEZ

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GLOBAL-TEC ENTERPRISES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064619. Last updated year: 2026. Please use registration number 1064619 when referencing this establishment in official correspondence.