Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004579179

FEI Number

3004579179

Entity Name

PRIME MEDICAL, INC.

City/State/Country

HWASEONG-SI Gyeonggi, KR

Establishment Address

335 Namyang-ro, Namyang-eup, HWASEONG-SI Gyeonggi 18269, KR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRIME MEDICAL, INC. (Owner Number: 9063831)

Owner / Operator Contact Address

335 Namyang-ro, Namyang-eup, --, HWASEONG-SHI, KR-41 18269, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PrimeNet DRY PrimeCOB PrimePad PrimeNet PrimeCrepe PrimeFix PrimeCutter PrimeSling PrimePOP Premium PrimeSoft PrimeCast

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-02-04
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2005-09-20
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	Class 1	888.5960	2011-12-12
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2019-02-04
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2005-03-15

Official Correspondent

Hugh Jeong Chang

US Agent Details

Stephan Toupin Business: Dawa Medical Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

PRIME MEDICAL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021043120	Prime Medica Promotion Private Limited	Vadodara Gujarat, IN

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

Similar Registrations

Registration Number	Establishment Name	Location
3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004579179. Last updated year: 2026. Please use registration number 3004579179 when referencing this establishment in official correspondence.