Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020614064

FEI Number

3020614064

Entity Name

NEXTBIOMEDICAL CO., LTD

City/State/Country

Incheon, KR

Establishment Address

6, Venture-ro 100beon-gil, Yeonsu-gu, Incheon 22013, KR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

NEXTBIOMEDICAL CO., LTD (Owner Number: 10084721)

Owner / Operator Contact Address

6, Venture-ro 100beon-gil, Yeonsu-gu, Incheon, KR-NOTA 22013, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240994

PMA Number

N/A

All Registered Proprietary Names

Nexpowder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2022-09-19
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2024-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

NEXTBIOMEDICAL CO., LTD

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2025	Wilson-Cook Medical Inc.	2	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Similar Registrations

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3014579161	WORLDWIDE SUPPLIES LIMITED	Hong Kong, HK
1036836	Sterigenics U.S., LLC	Haw River, NC, US
3002807408	KOGA ISOTOPE LTD.	Koka-shi Shiga, JP
3004681519	Sterigenics Belgium Fleurus SA	Fleurus Hainaut, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020614064. Last updated year: 2026. Please use registration number 3020614064 when referencing this establishment in official correspondence.