Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043503913

FEI Number

3043503913

Entity Name

SHINEO TECHNOLOGY CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

5F., No.207-4, Xinshu Rd., Xinzhuang Dist., New Taipei City 242, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shineo Technology CO., LTD. (Owner Number: 10095033)

Owner / Operator Contact Address

5F., No.207-4, Xinshu Rd., Xinzhuang Dist., New Taipei City, TW-NOTA 242, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EION Wound Dressing (Non-Sterile) AHC Platelet Concentrate Separator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2026-02-04
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2026-01-16

Official Correspondent

Lucan Ho

US Agent Details

Jeffrey Dahlen Business: Hikari Dx, Inc. Email: jeff@hikaridx.com Phone: (619) 7420203

Related Public Records

Same Entity

Shineo Technology 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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3016445778	LABNPEOPLE	Yangju-si Gyeonggi, KR
3033273018	RASHENDZ, INC.	St Petersburg, FL, US
3008656870	DALIAN ORIENTECH CO.,LTD	Dalian Liaoning, CN
1629057	WINFIELD LABORATORIES, INC.	Richardson, TX, US
3021695082	BEONE CO., LTD.	Gimpo Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043503913. Last updated year: 2026. Please use registration number 3043503913 when referencing this establishment in official correspondence.