Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012270469

FEI Number

3012270469

Entity Name

Allgens Medical Technology Co.,Ltd.

City/State/Country

Beijing, CN

Establishment Address

1st floor and Rooms 201-209,301-306,2nd Building,No.26 Yongwang west road,Daxing district, Beijing 102609, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Allgens Medical Technology Co.,Ltd (Owner Number: 10050079)

Owner / Operator Contact Address

1st floor and Rooms 201-209,301-306,2nd Building,No.26 Yongwang west road,Daxing district, Beijing, CN-BJ 102609, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141725

PMA Number

N/A

All Registered Proprietary Names

Bongold

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	2015-10-10

Official Correspondent

No official correspondent registered.

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Allgens Medical Technology 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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012270469. Last updated year: 2026. Please use registration number 3012270469 when referencing this establishment in official correspondence.