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implantcast GmbH

Germany · Buxtehude Lower Saxony

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 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

24listed device types

Class I 14Class II 10Class III 0

plus 34 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 9Class II 2

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

166active ARTG entries

Class I 4Class III 142IIa 3IIb 17

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

5registrations

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 States34 registration records, 20 510(k), 0 PMA

Brazil11 confirmed, 0 excluded

Manufacturer names merged into this page: implantcast GmbH · IMPLANTCAST GMBH · Implantcast GmbH

FDA 510(k) clearances by year

12017

12018

22019

22020

22021

22022

22023

42024

12025

32026

FDA listed device types

showing 8 of 24

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented 1Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented 1Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented 1Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252451	EPORE® XO cup system	2026-04-24
US	K260037	implantcast Packaging System Update	2026-03-30
US	K252401	implaFit® short stems	2026-03-12
BR	80454380084	KIT INSTRUMENTAL Sistema MUTARS Tumores Ósseos	Class I
BR	80454380060	Kit Instrumental para quadril	Class I
BR	80454380104	Instrumental Cirurgico SA20491	Class I

implantcast GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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