Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017635043

FEI Number

3017635043

Entity Name

PT. Jayamas Medica Industri Tbk

City/State/Country

Sidoarjo Jawa Timur, ID

Establishment Address

Sebelah Selatan Jalan By Pass, Ds., Sidomojo, Krian, Sidoarjo Jawa Timur 61262, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

One Medical Health Care (Owner Number: 10078103)

Owner / Operator Contact Address

Sebelah Selatan Jalan By Pass, Ds., Sidomojo, Krian, Sidoarjo, ID-JI 61262, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

One Medical Alcohol Pad One Medical Urine Specimen Container One Medical Syringe One Medical Head Feeding Tube Kit One Medical Syringe One Medical Lubricant One Medical Suction

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2020-10-10
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2020-10-10
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2021-05-19
BZS	Stethoscope Head	Anesthesiology	Class 1	868.1930	2020-10-10
PRR	Feeding Tube Kit	Gastroenterology, Urology	Class 2	876.5980	2025-06-01
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2021-05-18
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2020-10-10
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2021-05-18

Official Correspondent

No official correspondent registered.

US Agent Details

william slevin Business: medapproval llc Email: qara@medapprovalllc.com Phone: (404) 5935005

Related Public Records

Same Entity

One Medical Health Care

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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Similar Registrations

Registration Number	Establishment Name	Location
3005750815	HOME AIDE DIAGNOSTICS, INC.	Deerfield Bch, FL, US
3013823570	GUANGZHOU BAOLI HARDWARE & ELECTRONIC CO.,LTD.	Guangzhou Guangdong, CN
3021282544	DONGYANG CITY YONOEL OUTDOOR PRODUCTS CO.,LTD	Dongyang Zhejiang, CN
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
3004704697	CAREMAX CO., LTD.	SUZHOU, JIANGSU PROVINCE, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017635043. Last updated year: 2026. Please use registration number 3017635043 when referencing this establishment in official correspondence.