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APATECH LIMITED

United Kingdom of Great Britain and Northern Ireland · Elstree

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia, Hong Kong — 6 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

4listed device types

Class I 0Class II 3Class III 0unclassified 1

plus 20 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1Class III 5

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States20 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: APATECH LTD. · APATECH LIMITED

Business registration

Company number: 04170515
Registration status: Active
Legal form: Private Limited Company
Incorporated: 2001-03-01
Principal activity: 20590 - Manufacture of other chemical products n.e.c.
Registered address: APATECH LIMITED 360 CENTENNIAL AVENUE, ELSTREE, WD6 3TJ

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

22004 · K040082

12007 · K071206

42008 · K082575

12009 · K090850

FDA listed device types

Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) 1Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Synthetic 1Wax, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K090850	ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE	2009-07-30
US	K082575	ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTES	2008-11-25
US	K081979	ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE	2008-11-06

APATECH LIMITED

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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