Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013497559

FEI Number

3013497559

Entity Name

Kaigen Pharma Co., Ltd. Tenjin Factory

City/State/Country

Otaru-shi Hokkaido, JP

Establishment Address

2-5-3 Tenjin, Otaru-shi Hokkaido 047-0011, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kaigen Pharma Co.,Ltd. (Owner Number: 10052192)

Owner / Operator Contact Address

2-5-3 Tenjin, Otaru-shi, JP-01 047-0011, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ReBOSSIS ReBOSSIS QDS ReBOSSIS QDS ReBOSSIS

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	2017-10-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

Floyd Larson Business: PAXMED INTERNATIONAL, LLC Email: flarson@paxmed.com Phone: (858) 7921235

Related Public Records

Same Entity

Kaigen Pharma 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

Similar Registrations

Registration Number	Establishment Name	Location
3007738819	OSferionBiomaterials Corp. Mishima Factory	Sunto-gun Shizuoka, JP
3019403037	HERAEUS MEDICAL LLC - BIORESOBABLES	Yardley, PA, US
3010376334	GEV Co., Ltd.	Eumseong-gun Chungbuk, KR
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 3013497559. Last updated year: 2026. Please use registration number 3013497559 when referencing this establishment in official correspondence.