Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030626362

FEI Number

3030626362

Entity Name

GOSTAR CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

2F., No. 65, Wuquan 7th Rd., Wugu Dist., New Taipei City 248020, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GOSTAR CO., LTD. (Owner Number: 10090367)

Owner / Operator Contact Address

2F., No. 65, Wuquan 7th Rd., Wugu Dist., New Taipei City, TW-NWT 248020, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221419

PMA Number

N/A

All Registered Proprietary Names

TD-7301 Peak Flow Meter FORA Spiro10b Peak Flow Meter TD-5010 Lancing Device and TD-5084 Sterile Lancets TD-5010 Lancing Device ; TD-THIN Sterile Lancets LIVE TULA Sterile lancets FORA LANCING DEVICE ; FORA STERILE LANCETS TD-5011 Lancing Device ; TD-THIN Sterile Lancets FORA gojji LANCING DEVICE ; FORA gojji STERILE LANCETS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2024-03-20
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2024-03-19
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-03-19

Official Correspondent

Pei-Fen Yang

US Agent Details

Sophia Wu Business: ForaCare Inc Email: Sophia-Agent@Foracare.Com Phone: (805) 4988188

Related Public Records

Same Entity

GOSTAR 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
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17

Similar Registrations

Registration Number	Establishment Name	Location
3008505660	eResearchTechnology GmbH	Estenfeld Bavaria, DE
1000604079	VINCENT MEDICAL MANUFACTURING. CO., LTD.	KOWLOON, HK
9614860	MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.	ROMA, IT
1317346	MONAGHAN MEDICAL CORP.	Plattsburgh, NY, US
9612777	TRUDELL MEDICAL INTERNATIONAL	LONDON Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030626362. Last updated year: 2026. Please use registration number 3030626362 when referencing this establishment in official correspondence.