Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023194894

FEI Number

3023194894

Entity Name

ANDAU MEDICAL CORP.

City/State/Country

Tukwila, WA, US

Establishment Address

923 INDUSTRY DRIVE, Tukwila, WA 98188, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Andau Medical Inc. (Owner Number: 10084312)

Owner / Operator Contact Address

10539 - 169 Street NW, Edmonton, CA-AB T5P 4Y7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Admetec Galilean Loupes Admetec Prismatic Loupes Admetec Ergonomic Loupes Admetec Orchid Admetec Orchid-S Admetec Orchid-F Admetec Butterfly S-EVO Admetec Orchid Ergo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2022-02-09
EBA	Light, Surgical Headlight	Dental	Class 1	872.4630	2026-04-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Andau Medical Inc.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1051614	PRACTICON, INC.	Greenville, NC, US
3025376090	Bothwin (Beijing) Medical Technology Co., Ltd.	Beijng Beijing, CN
3003969012	Alltion (Guangxi) Instrument Co., Ltd.	Wuzhou City Guangxi, CN
2431166	Sklar Corporation	West Chester, PA, US
3009768364	Foshan CICADA Dental Instrument Co., Ltd.	Foshan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023194894. Last updated year: 2026. Please use registration number 3023194894 when referencing this establishment in official correspondence.