HomeGermanyMERZ DENTAL GMBH

MERZ DENTAL GMBH

Germany · Lutjenburg
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Russia — 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
8listed device types
Class I 2Class II 5Class III 0unclassified 1
plus 11 registration records and 9 510(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
13 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 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, 9 510(k), 0 PMA, 6 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: MERZ DENTAL GMBH

Company information

Country
Germany
City
Lutjenburg

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12003
12006
12007
12008
12012
12013
22014
12017

FDA listed device types

Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1Denture Preformed (Partially Prefabricated Denture) 1Crown And Bridge, Temporary, Resin 1Denture, Plastic, Teeth 1Material, Impression Tray, Resin 1Wax, Dental, Intraoral 1Mouthguard, Prescription 1

Registration details (sample)

MarketIdentifierNameClass / date
USK173124PEEK Biosolution2017-12-18
USK140758M-PM-DISC (PINK)2014-09-15
USK134015M-PM-DISC2014-04-11

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