Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014982332

FEI Number

3014982332

Entity Name

ACRO BIOMEDICAL CO., LTD.

City/State/Country

Kaohsiung, TW

Establishment Address

3rd Fl., No.57, Luke 2nd Rd., Luzhu Dist., Kaohsiung 82151, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACRO Biomedical Co., Ltd. (Owner Number: 10059025)

Owner / Operator Contact Address

3rd Fl., No.57, Luke 2nd Rd., Luzhu Dist., Kaohsiung, TW-KHH 82151, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162348

PMA Number

N/A

All Registered Proprietary Names

ABCcolla® Collagen ADM Scaffold ABCcolla® External Aesthetic Restoration Prosthesis Scar Care Gel Scar Care Spray ABCcolla® Scar Spray ABCcolla® Scar Care Dressing ABCcolla® Scar Gel ABCcolla® Bone Graft ABCcolla® Collagen Matrix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2024-11-05
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2018-11-26
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2018-11-26
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-11-26
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2018-11-26

Official Correspondent

DAR-JEN HSIEH

US Agent Details

Blue Kick LLC Blue Kick LLC Business: Blue Kick LLC Email: info@bluekick.com Phone: (513) 3484677

Related Public Records

Same Entity

ACRO Biomedical Co., Ltd.

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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30

Similar Registrations

Registration Number	Establishment Name	Location
3014498807	FETTECH	Davie, FL, US
3042617688	LMC OPCO, LLC	Woodstock, GA, US
3004189237	ADVANCED BIOTECH PRODUCTS (P), LTD.	CHENNAI Tamil Nadu, IN
3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014982332. Last updated year: 2026. Please use registration number 3014982332 when referencing this establishment in official correspondence.