Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021015512

FEI Number

3021015512

Entity Name

BIOSTONE CO. LTD.

City/State/Country

Nottingham Nottinghamshire, GB

Establishment Address

Biocity Nottingham, Pennyfoot Street, Nottingham Nottinghamshire NG1 1GF, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biostone Co. Ltd. (Owner Number: 10083269)

Owner / Operator Contact Address

Biocity Nottingham, Pennyfoot Street, Nottingham, GB-NTT NG1 1GF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioViveSBG (1DE-OBS-01) System 2 BA-MIS (SYS2-05M) si-MochiX (XOBS1205) Bio-Reign Luxe (BRL-1) InteliGraft (IG-SBG10) InteliGraft (IG-MIS-SBG10) si-Mochi VET1205-M si-Mochi OBS1203 si-Mochi VET1205-O si-Mochi VET1210-M si-Mochi OBS1205 si-Mochi OBS1201 si-Mochi VET1203-O SynthaGen HaTCP (OBS-1210-FO) si-Mochi VET1202-O SynthaGen HaTCP (OBS-1201-FO) OsteoXcell BA (OSBA-005M) OsteoXcell BA (OSBA-002) OsteoXcell BA (OSBA-001) si-Mochi OBS1210 Apex ASG (966-1205) si-Mochi MIS1205 Apex ASG (965-1201) OsteoXcell BA (OSBA-003) Apex ASG (965-1205) si-Mochi VET1210-O SynthaGen HaTCP (OBS-1203-FO) Apex ASG (965-1210) System 2 BA (SYS2-02) System 2 BA (SYS2-10) System 2 BA-MIS (SYS2-10M) System 2 BA (SYS2-01) Apex ASG (965-1202) SynthaGen HaTCP (MIS-1205-FO) SynthaGen HaTCP (OBS-1205-FO) BioViveSBG (1DE-OBS-05) BioViveSBG (1DE-MIS-10) SynthaGen HaTCP (OBS-1202-FO) Bio-Reign Luxe (BRL-5) System 2 BA (SYS2-05) BioViveSBG (1DE-MIS-05) InteliGraft (IG-SBG02) Bio-Reign Luxe (BRL-3) Bio-Reign Luxe (BRL-10) InteliGraft (IG-SBG03) si-MochiX (XOBS1203) OsteoXcell BA (OSBA-010M) OsteoXcell BA (OSBA-005) InteliGraft (IG-SBG05) InteliGraft (IG-MIS-SBG05) BioViveSBG (1DE-OBS-02) SynthaGen HaTCP (MIS-1210-FO) si-Mochi VET1201-O si-Mochi MIS1210 si-Mochi OBS1202 OsteoXcell BA (OSBA-010) Apex ASG (965-1203) BioViveSBG (1DE-OBS-10) Apex ASG (966-1210) BioViveSBG (1DE-OBS-03) InteliGraft (IG-SBG01) System 2 BA (SYS2-03)

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	2021-11-08

Official Correspondent

Wei-Jen Lo

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Biostone 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021015512. Last updated year: 2026. Please use registration number 3021015512 when referencing this establishment in official correspondence.