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Mondeal Medical Systems GmbH

Germany · Amsterdam

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 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

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 1IIa 1IIb 1Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States0 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Manufacturer names merged into this page: MONDEAL MEDICAL SYSTEMS GMBH · Mondeal Medical Systems GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K072740	MONDEAL EXTREMITY BONE FIXATION SYSTEM	2007-11-19
US	K071798	MONDEAL DISTAL RADIUS SYSTEM	2007-09-17
US	K071797	MONDEAL HAND CONTOUR SYSTEM	2007-09-17
BR	10356509003	TRITURADOR DE OSSO MONDEAL - BULL BONE MILL	Class I
SA	ME0000004553SFDAA00001	Locking pieces for MBM	—
SA	ME0000004556SFDAA00001	MBM Bone Mill Basic Body	—

Mondeal Medical Systems GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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