ELASTOMADE ACCESSORIES SDN BHD

FDA Device Registration & Listing · Port Klang Selangor, MY · Registration 3005822857

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005822857
FEI Number
3005822857
Entity Name
ELASTOMADE ACCESSORIES SDN BHD
City/State/Country
Port Klang Selangor, MY
Establishment Address
Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara, Port Klang Selangor 42000, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ELASTOMADE ACCESSORIES SDN BHD (Owner Number: 9001465)
Owner / Operator Contact Address
Lot 7, Lengkungan Hishamuddin, Kawasan Perusahaan Selat Klang Utara, Port Klang, MY-10 42000, MY
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Dental Dam Royal Shield Latex Free Dental Dam

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIE Dam, Rubber Dental Class 1 872.6300 2008-04-07

Official Correspondent

Bee Hong Ooi

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

ELASTOMADE ACCESSORIES 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
K040797 Britesmile, Inc. BRITESMILE MASKING CREAM 2004-04-02

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1424442 PRIME DENTAL MANUFACTURING, INC. CHICAGO, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005822857. Last updated year: 2026. Please use registration number 3005822857 when referencing this establishment in official correspondence.
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