Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027568582

FEI Number

3027568582

Entity Name

ATMO BIOSCIENCES LTD

City/State/Country

Box Hill Victoria, AU

Establishment Address

436 Elgar Rd, Box Hill Victoria 3128, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Atmo Biosciences Ltd (Owner Number: 10093741)

Owner / Operator Contact Address

436 Elgar Rd, Box Hill, AU-VIC 3128, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250940

PMA Number

N/A

All Registered Proprietary Names

Atmo Gas Capsule System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NYV	Gastrointestinal Motility System, Capsule	Gastroenterology, Urology	Class 2	876.1725	2025-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Matt Kyle Business: Kuro Medical LLC Email: quality@kuromedical.com Phone: (612) 6362035

Related Public Records

Same Entity

Atmo Biosciences Ltd

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3017496797	Kuro Medical	Eden Prairie, MN, US
3016544248	ANX ROBOTICA CORP.	Plano, TX, US
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
9710107	GIVEN IMAGING LTD.	Yoqneam Northern, IL
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027568582. Last updated year: 2026. Please use registration number 3027568582 when referencing this establishment in official correspondence.