Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005977696

FEI Number

3005977696

Entity Name

MEDICAL DEVELOPMENTS INTERNATIONAL

City/State/Country

Scoresby Victoria, AU

Establishment Address

4 Caribbean Drive, Scoresby Victoria 3179, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medical Developments International (Owner Number: 10044454)

Owner / Operator Contact Address

4 Caribbean Drive, Scoresby, AU-VIC 3179, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143615

PMA Number

N/A

All Registered Proprietary Names

Silicone Face Mask - Medium Silicone Face Mask - Small Silicone Face Mask - Large Antistatic Silicone Face Mask - Large Antistatic Silicone Face Mask - Medium Antistatic Silicone Face Mask - Small Antistatic Compact Space Chamber Asthma Chamber

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2014-06-25
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2016-03-29

Official Correspondent

Julianne Alexander

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Medical Developments International

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

View Entity Profile →

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9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3015665020	GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005977696. Last updated year: 2026. Please use registration number 3005977696 when referencing this establishment in official correspondence.