Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038614708

FEI Number

3038614708

Entity Name

PT. JAYAMAS MEDICA INDUSTRI TBK

City/State/Country

Jombang Jawa Timur, ID

Establishment Address

Dusun Karangmenjangan, Desa Karangwinongan, Kec. Mojoagung, Kab., Jombang Jawa Timur 61482, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT. JAYAMAS MEDICA INDUSTRI TBK (Owner Number: 10093542)

Owner / Operator Contact Address

Dusun Karangmenjangan, Desa Karangwinongan, Kec. Mojoagung, Kab., Jombang, ID-JI 61482, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioSieve Multi-Drugs Using Test Cup BioSieve Multi Drigs Urine Test Cup

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-06-01
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-06-01
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-06-01
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2025-06-01
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-06-01
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-06-01
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-06-01
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-06-01
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-06-01
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-06-01
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-06-01

Official Correspondent

William Slevin

US Agent Details

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

Related Public Records

Same Entity

PT. JAYAMAS MEDICA INDUSTRI TBK

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
K924751	Solarcare Technologies Corp,Inc.	SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY	1992-12-11
K142044	Guangzhou Wondfo Biotech Co., Ltd.	CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE	2014-08-25
K163220	Siemens Healthcare Diagnostics, Inc.	Atellica CH Phencyclidine (Pcp)	2017-04-06
K241741	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel	2024-07-16
K252550	Guangzhou Wondfo Biotech Co., Ltd.	SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx	2025-11-18

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3009585529	ASSURE TECH. (HANGZHOU) CO., LTD.	Hangzhou Zhejiang, CN
3024463179	ACESO LABORATORIES INC.	Chino, CA, US
3043127647	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038614708. Last updated year: 2026. Please use registration number 3038614708 when referencing this establishment in official correspondence.