Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043606675

FEI Number

3043606675

Entity Name

PT VITANOVA MEDICAL INDONESIA

City/State/Country

Kec. Cikarang Pusat, Kab. Bekasi Jawa Barat, ID

Establishment Address

Kawasan Industri Delta Silicon 6, Jalan Ramin II Blok G6 Nomor 18A, Desa/Kelurahan Jayamukti, Kec. Cikarang Pusat, Kab. Bekasi Jawa Barat 17531, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT VITANOVA MEDICAL INDONESIA (Owner Number: 10094280)

Owner / Operator Contact Address

Kawasan Industri Delta Silicon 6, Jalan Ramin II Blok G6 Nomor 18A, Desa/Kelurahan Jayamukti, Kec. Cikarang Pusat, Kab. Bekasi, ID-JB 17531, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-Conductive Suction Tubing CONNECTING TUBE YANKAUER SUCTION HANDLE Connecting Tube with or without Yankauer Handle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2026-02-08
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2026-02-08

Official Correspondent

Jenny ZHU

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

PT VITANOVA MEDICAL INDONESIA

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
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
2953726	ADDITION TECHNOLOGY, INC.	Lombard, IL, US
3043534762	AVANTTI MEDI CLEAR MBP, S.A.P.I. DE C.V.	TIJUANA Baja California, MX
3011252788	Changzhou Rongxin Medicine Minimal Invasion Technology Co., Ltd	Jintan Jiangsu, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3031231776	Perfect Ophthalmic Instruments FZE	Dubai Dubayy, AE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043606675. Last updated year: 2026. Please use registration number 3043606675 when referencing this establishment in official correspondence.