Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010376334

FEI Number

3010501626

Entity Name

GEV Co., Ltd.

City/State/Country

Eumseong-gun Chungbuk, KR

Establishment Address

37-10, Maengdongsandan-ro, Maengdong-myeon, Eumseong-gun Chungbuk 27733, KR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

GEV Co., Ltd. (Owner Number: 10043696)

Owner / Operator Contact Address

37-10, Maengdongsandan-ro, Maengdong-myeon, Eumseong-gun, KR-43 27733, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SurFuse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-03-12
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2013-03-12

Official Correspondent

Sangsoo Lee

US Agent Details

Kevin Chun Business: Hans Biomed USA, Inc. Email: qra@hansbiomed.us Phone: (562) 6156813

Related Public Records

Same Entity

GEV 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
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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3043620406	REVOGEN BIOLOGICS	San Antonio, TX, US
3016050940	Olive Branch Distribution Center	Olive Branch, MS, US
1526439	DEPUY SPINE, INC.	RAYNHAM, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010376334. Last updated year: 2026. Please use registration number 3010376334 when referencing this establishment in official correspondence.