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Home›Switzerland›SYNTHES PRODUKTIONS GMBH

SYNTHES PRODUKTIONS GMBH

Switzerland
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 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
27listed device types
Class I 9Class II 18Class III 0
plus 32 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
4 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States32 registration records, 0 510(k), 0 PMA, 7 excluded
Brazil2 confirmed, 1 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SYNTHES GMBH / Synthes Produktions GmbH · SYNTHES PRODUKTIONS GMBH
Same-named companies — This database also contains companies with near-identical names: SYNTHES GMBH / Synthes Produktions GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Switzerland

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 listed device types

showing 8 of 27
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Filler, Bone Void, Calcium Compound 1Rod, Fixation, Intramedullary And Accessories 1Driver, Wire, And Bone Drill, Manual 1Staple, Fixation, Bone 1Plate, Bone 1Motor, Drill, Pneumatic 1Pin, Fixation, Smooth 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80145901588MOTOR ELÉTRICO COLIBRI IIClass II
BR80145901589MOTOR ELETRICO PARA USO ORTOPEDICO SYNTHESClass II

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