Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006251250

FEI Number

3006251250

Entity Name

EVAN INDUSTRIAL CO, LTD.

City/State/Country

Taoyuan City, TW

Establishment Address

8F-4, No.208, Shou Shan Road, Taoyuan City 330, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EVAN INDUSTRIAL CO, LTD. (Owner Number: 9093886)

Owner / Operator Contact Address

NO.48, JEN SHOU LANE, SHOU SHAN RD, KUEI SHAN, SHIANG, TAOYUAN CNT, TAIWAN, TW-NOTA 33354, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080448

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2011-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

KAREN KOWALCZYK KOWALCZYK Business: Centurion Medical Products, LP Email: kkowalczyk@centurionmp.com Phone: (517) 5465400

Related Public Records

Same Entity

EVAN 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
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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3027592416	VIPER EMERGENCY MEDICAL RESTRAINTS, LLC	Shrewsbury, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006251250. Last updated year: 2026. Please use registration number 3006251250 when referencing this establishment in official correspondence.