Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007515605

FEI Number

3007515605

Entity Name

STURDY INDUSTRIAL CO., LTD.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

NO. 168, SEC. 1, ZHONGXING RD., WUGU DISTRICT,, NEW TAIPEI CITY 24872, TW

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

STURDY INDUSTRIAL CO., LTD. (Owner Number: 10061891)

Owner / Operator Contact Address

NO. 168, SEC. 1, ZHONGXING RD., WUGU DISTRICT,, NEW TAIPEI CITY, TW-TPE 24872, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231489

PMA Number

N/A

All Registered Proprietary Names

AGNeovo Autoclave LouieP Series (model: P-M10T) STURDY Autoclave Super Microm (Model: SA-260MA) AGNeovo Autoclave LouieP Series (model: P-M10TR) STURDY Autoclave Super Microm (Model: SA-260MA-R) STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2019-11-29
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2024-11-12

Official Correspondent

Wolfgang Huang

US Agent Details

Fang Yu Chu Email: elsa.chu@wellell.com Phone: (714) 6713818

Related Public Records

Same Entity

STURDY INDUSTRIAL CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21

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8030087	TUTTNAUER LTD.	BEIT SHEMESH Jerusalem, IL
3022516928	DENT4YOU AG	Heerbrugg Sankt Gallen, CH
3012068831	Getinge IC Production Poland sp. z o.o.	Plewiska Wielkopolskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007515605. Last updated year: 2026. Please use registration number 3007515605 when referencing this establishment in official correspondence.