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WALDEMAR LINK GMBH AND CO. KG

Germany · Hamburg

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

68listed device types

Class I 46Class II 22Class III 0

plus 98 registration records and 43 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 24

49 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

6active device licences

Class III 6

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States98 registration records, 43 510(k), 0 PMA, 1 excluded

Brazil24 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Waldemar Link GmbH & Co. KG · WALDEMAR LINK GMBH AND CO. KG · WALDEMAR LINK GMBH & CO. KG · WALDEMAR LINK GMBH & CO · WALDEMAR LINK GMBH & CO.G

FDA 510(k) clearances by year

21978

21979

11980

11984

31985

12005

12014

22015

12016

12017

12018

62019

22020

72021

52022

32023

12024

22025

12026

FDA listed device types

showing 8 of 68

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261009	MobileLink Acetabular Cup System 40mm ID Inserts (various)	2026-07-06
US	K250375	Allure Hip Stem and Intramedullary Plugs	2025-11-05
US	K243927	MobileLink Acetabular Cup System - inhouse coatings	2025-05-16
BR	81346500038	INSTRUMENTAL ENDO-MODEL	Class I
BR	10247530119	CONJUNTO DE INSTRUMENTOS DE JOELHO LINK	Class I
BR	10247530120	CONJUNTO DE INSTRUMENTOS DE QUADRIL LINK	Class I
SA	ME0000009859SFDAA00035	F GEMINI SPAR-K Instrument Set	—
SA	ME0000009859SFDAA00079	Link@ Complementary Instrument Set	—
CA	70445	LINK PROSTHESIS "B" SPII FEMORAL HEADS COBALT CHROME	Class III
CA	70446	LINK PROSTHESIS "A" SPII FEMORAL HEADS CERAMIC	Class III
CA	71046	LINK S.T.A.R. ANKLE (SCANDINAVIAN TOTAL ANKLE REPLACEMENT)	Class III

WALDEMAR LINK GMBH AND CO. KG

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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