Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616419

FEI Number

3003656001

Entity Name

SUNDER BIOMEDICAL TECH. CO., LTD.

City/State/Country

Yunlin County, TW

Establishment Address

No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang,, Yunlin County 63441, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUNDER BIOMEDICAL TECH. CO., LTD. (Owner Number: 9040038)

Owner / Operator Contact Address

No. 16, Chung-Chen Rd., Chung-Ming Village, Pao-Chung Hsiang, TW-YUN 63441, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SUNDER SUCTION BAG Set, tubing, blood, with and without anti-regurgitation valve Needle, fistula TRANSDUCER, GAS PRESSURE SUNDER nasal oxygen cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-09-25
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2007-08-29
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2016-11-21
BXO	Transducer, Gas Pressure	Anesthesiology	Class 1	868.2900	2010-09-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-09-25

Official Correspondent

Kevin Hu

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

SUNDER BIOMEDICAL TECH. 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
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616419. Last updated year: 2026. Please use registration number 9616419 when referencing this establishment in official correspondence.