HomeTürkiyeKonfort Ozel Saglik Hiz. Tibbi Malz. San. ve Tic. Ltd. Sti

Konfort Ozel Saglik Hiz. Tibbi Malz. San. ve Tic. Ltd. Sti

Türkiye · Eskisehir · www.confortostomi.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN TR-MF-000014934

This company has registrations in European Union, United States, Brazil, Saudi Arabia — 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
76UDI-DI device records
Class I 62Class IIa 3Class IIb 4Class III 7
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
6registered devices
Class I 6
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered 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
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.

European Union76 raw hits, 0 excluded, 76 confirmed
United States1 registration records, 0 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: KONFORT OZEL SAGLIK HIZMETLERI TIBBI MALZ. SAN VE TIC LTD STI · KONFORT ÖZEL SA&#286.LIK H&#304.ZMETLER&#304. TIBB&#304. MALZ. SAN. T&#304.C. LTD.&#350.T& · Konfort Özel Sağlık Hizmetleri Tıbbi Malz. Sanayi ve Tic.Ltd.Şti · KONFORT ÖZEL SAĞLIK HİZMETLERİ TIBBİ MALZEMELER SANAYİ VE TİCARET LİMİTED ŞİRKETİ

Regulatory identity

EU manufacturer SRN
TR-MF-000014934

Company information

Country
Türkiye
City
Eskisehir
Website
www.confortostomi.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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

Collector, Ostomy 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08680014004878CONFORTClass IIb
EU08680014004687CONFORTClass IIb
EU08680014004755CONFORTClass IIb
EU08680014004779CONFORTClass IIb
BR81606090056Confort 2 peças - Bolsa para UrostomiaClass I
BR81606090057Clips de Fechamento para Bolsa de OstomiaClass I
BR81606090058Confort FlangeClass I
SAME0000020024SFDAA00004CONFORT
SAME0000020024SFDAA00015CONFORT

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