Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014716786

FEI Number

3014716786

Entity Name

FLAT MEDICAL CO., LTD.

City/State/Country

Taipei, TW

Establishment Address

12F.-2, No. 206, Sec. 2, Nanjing E. Rd.,, Zhongshan Dist., Taipei 104496, Taiwan, Taipei 104496, TW

Establishment Type(s)

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

Owner / Operator

Flat Medical Co., Ltd. (Owner Number: 10060448)

Owner / Operator Contact Address

12.-2, No. 206, Sec. 2, Nanjing E. Rd.,, Zhongshan Dist., Taipei 104496, Taiwan, Taipei, TW-TPE 104496, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182268

PMA Number

N/A

All Registered Proprietary Names

EpiFaith Syringe (Luer Slip), EpiFaith Syringe (NRFit)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-05-29

Official Correspondent

Shao Wei Tseng

US Agent Details

Jack Taber Business: SUN DESIGNE LTD. OF FLORIDA Email: jack.taber@gmail.com Phone: (772) 2887466

Related Public Records

Same Entity

Flat Medical 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014716786. Last updated year: 2026. Please use registration number 3014716786 when referencing this establishment in official correspondence.