Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017373426

FEI Number

3017373426

Entity Name

ADVANCED BIO MACHINES PTE. LTD.

City/State/Country

SINGAPORE Central Singapore, SG

Establishment Address

36 Robinson Road, #20-01 City House, SINGAPORE Central Singapore 068877, SG

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Advanced Bio Machines Pte. Ltd. (Owner Number: 10083610)

Owner / Operator Contact Address

36 Robinson Road, #20-01 City House, SINGAPORE, SG-01 068877, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191912

PMA Number

N/A

All Registered Proprietary Names

BiWaze Clear System BiWaze Clear System BIWAZE COUGH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2022-12-31
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2025-01-06
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	Class 2	868.5905	2021-12-06

Official Correspondent

Priyanka Paul

US Agent Details

Leah Noaeill Business: ABMRC LLC Email: leah.noaeill@abmrc.com Phone: (612) 4191071

Related Public Records

Same Entity

Advanced Bio Machines Pte. Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017373426. Last updated year: 2026. Please use registration number 3017373426 when referencing this establishment in official correspondence.