Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021043120

FEI Number

3021043120

Entity Name

Prime Medica Promotion Private Limited

City/State/Country

Vadodara Gujarat, IN

Establishment Address

E/96 GIDC Manjusar, Savli Road, Vadodara Gujarat 391775, IN

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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXT	Tape, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2005-03-15
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
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2004-05-28
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

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
3004579179	PRIME MEDICAL, INC.	HWASEONG-SI Gyeonggi, KR

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
3006554912	STERIS Deutschland GmBh	Wurmlingen Baden-Wurttemberg, DE
3004526603	RICHARDSON PRODUCTS, INC.	FRANKFORT, IL, US
3027500264	BREG MEXICO, S. DE R.L. DE C.V. (4)	Mexicali Baja California, MX
1030489	MEDTRONIC SOFAMOR DANEK USA, INC.	Memphis, TN, US
3006897996	HOSPITAL & HOMECARE IMP. & EXP. CO., LTD	NANJING Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021043120. Last updated year: 2026. Please use registration number 3021043120 when referencing this establishment in official correspondence.