Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010018659

FEI Number

3010018659

Entity Name

BIOPTIK TECHNOLOGY, INC. HSINCHU SCIENCE PARK BRANCH

City/State/Country

Hsinchu City, TW

Establishment Address

1F, No.18, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu City 30077, TW

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bioptik Technology, Inc. Hsinchu Science Park Branch (Owner Number: 10093732)

Owner / Operator Contact Address

1F, No.18, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu City, TW-HSQ 30077, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dressing, Wound, Hydrogel Without Drug And/Or Biologic Silicone hydrogel for scar management

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2025-06-30
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-06-30

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Bioptik Technology, Inc. Hsinchu Science Park Branch

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3038014307	CURAPEP LLC	Burlington, WI, US
3043012215	ZENESIS HOLDINGS CO., LIMITED	Kowloon, HK
3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010018659. Last updated year: 2026. Please use registration number 3010018659 when referencing this establishment in official correspondence.