Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009669249

FEI Number

3009669249

Entity Name

EPSILON MEDICAL DEVICES SDN BHD.

City/State/Country

Kamunting Perak, MY

Establishment Address

Lot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, Kamunting Perak 34600, MY

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Epsilon Medical Devices Sdn Bhd. (Owner Number: 10061247)

Owner / Operator Contact Address

Lot 5271, Jalan Perusahaan 3, Kamunting Industrial Estate, Kamunting, MY-08 34600, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2019-10-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Epsilon Medical Devices Sdn Bhd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009669249. Last updated year: 2026. Please use registration number 3009669249 when referencing this establishment in official correspondence.