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Home›Germany›SCHEU-DENTAL custom-made GmbH

SCHEU-DENTAL custom-made GmbH

Germany · Hilden North Rhine-Westphalia
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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 4Class II 0Class III 0
plus 5 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 3Class II 3
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
6 including historic records
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 States5 registration records, 1 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: SCHEU-DENTAL GMBH · SCHEU-DENTAL custom-made GmbH · SCHEU DENTAL GMBH
Same-named companies — This database also contains companies with near-identical names: SCHEU-DENTAL GMBH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Hilden North Rhine-Westphalia

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

11989 · K883418

FDA listed device types

Positioner, Tooth, Preformed 1Retainer, Screw Expansion, Orthodontic 1Clasp, Preformed 1Wire, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK883418DE-BOND 2001989-10-24
BR10241250034PLACA ORTODÔNTICA SCHEU-DENTAL DURAN+Class I
BR10241250035PLACA SCHEU-DENTAL DURASOFT pdClass I
BR10241250036PLACA ORTODÔNTICA SCHEU-DENTAL DURANClass I

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