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Home›Germany›SCHEU-DENTAL GMBH

SCHEU-DENTAL GMBH

Germany · Iserlohn
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Russia — 7 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
8valid device licences
Class I 8
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
6active ARTG entries
Class I 4IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 custom-made GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Germany
City
Iserlohn

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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