Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039394934

FEI Number

3039394934

Entity Name

PT ACE MEDICAL PRODUCTS INDONESIA

City/State/Country

Kedawung, Banyuputih, Batang Regency, Jawa Barat, ID

Establishment Address

(Unit A18 - A21) Jl. Akasia, Mangunsari, Kawasan Industri Terpadu Batang (KITB), Kedawung, Banyuputih, Batang Regency, Jawa Barat 51271, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT Ace Medical Products Indonesia (Owner Number: 10093685)

Owner / Operator Contact Address

(Unit A18 - A21) Jl. Akasia, Mangunsari, Kawasan Industri Terpadu Batang (KITB), Kedawung, Banyuputih, Batang Regency, Central Java, ID-NOTA 51271, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drape OR Towel OB pad ABD pad, Non-stick Pad, Post-sponge (Tissue & Cotton), Post-sponge (Tissue) conforming bandages

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-06-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2025-06-23
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2025-06-23
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2025-06-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2025-06-23

Official Correspondent

Vince Tian

US Agent Details

Jessie Yao Business: Medright Tech Inc Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

PT Ace Medical Products 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
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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039394934. Last updated year: 2026. Please use registration number 3039394934 when referencing this establishment in official correspondence.