Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005315793

FEI Number

3005315793

Entity Name

BACTIGUARD (South East Asia) Sdn. Bhd.

City/State/Country

Penang Science Park Pulau Pinang, MY

Establishment Address

308 b, Jalan Perindustrian Bukit Minyak 18, Penang Science Park Pulau Pinang 14100, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BACTIGUARD (South East Asia) Sdn. Bhd. (Owner Number: 10048749)

Owner / Operator Contact Address

308 b,, Jalan Perindustrian Bukit Minyak 18,, Penang Science Park, MY-07 14100, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142775

PMA Number

N/A

All Registered Proprietary Names

Neuwater Hydrocyn aqua Medocyn Redoxcyn

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

Sebastian Feye Business: ACCURATE CONSULTANTS INC Email: sebastian@accuratefdaconsulting.com Phone: (619) 5170673

Related Public Records

Same Entity

BACTIGUARD (South East Asia) Sdn. Bhd.

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005315793. Last updated year: 2026. Please use registration number 3005315793 when referencing this establishment in official correspondence.