Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009987158

FEI Number

3009987158

Entity Name

AMT PTE. LTD.

City/State/Country

Singapore South West, SG

Establishment Address

3 Tuas Lane, Singapore South West 638612, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AMT PTE. LTD. (Owner Number: 10079864)

Owner / Operator Contact Address

3 Tuas Lane, Singapore, SG-05 638612, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213564

PMA Number

N/A

All Registered Proprietary Names

BiWaze Clear System

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	2023-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

AMT 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 3009987158. Last updated year: 2026. Please use registration number 3009987158 when referencing this establishment in official correspondence.