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Biocomposites, Ltd.

United Kingdom of Great Britain and Northern Ireland · Keele

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 2Class II 8Class III 0

plus 11 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class III 2

9 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

3device registrations

CLASS B 1CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class III 10IIa 1

HKHong KongMDACS

3valid listings

Class II 1Class IV 2

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 27 510(k), 0 PMA, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BIOCOMPOSITES LTD. · BIOCOMPOSITES LTD

Business registration

Legal name: BIOCOMPOSITES LIMITED
Company number: 03291943
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1996-12-13
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: C/O BIOCOMPOSITES LIMITED KEELE SCIENCE PARK, NEWCASTLE, ST5 5NL

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

32000

22001

22002

32004

22005

22006

42007

42008

12015

12022

22025

12026

FDA listed device types

showing 8 of 10

Orthopedic Manual Surgical Instrument 1Template 1Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Filler, Bone Void, Calcium Compound 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Staple, Fixation, Bone 1Screw, Fixation, Bone 1Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251680	Biosteon® Screw	2026-02-17
US	K242865	Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer	2025-06-12
US	K250521	NanoBone® SBX Putty ; NanoBone® QD	2025-04-07
CA	62889	BIOSTEON CROSS PIN SYSTEM	Class III
CA	80661	POWERPLAY SUTURE IMPLANT	Class III

Biocomposites, Ltd.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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