HomeTürkiyeAygun Surgical Instruments Co., Inc.

Aygun Surgical Instruments Co., Inc.

Türkiye · Samsun · www.aygun.com
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan — 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
0UDI-DI device records
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
10registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
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 States2 registration records, 1 510(k), 0 PMA
Brazil1 confirmed, 2 excluded
Saudi Arabia10 confirmed, 0 excluded
Manufacturer names merged into this page: AYGUN SURGICAL INSTRUMENTS CO.,INC. · AYGUN SURGICAL INSTRUMENTS CO INC · AYGUN SURGICAL INSTRUMENTS CO.,INC · Aygun Surgical Instruments Co., Inc · Aygun Surgical Instruments Co. Inc

Company information

Country
Türkiye
City
Samsun
Website
www.aygun.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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

12023 · K233222

FDA listed device types

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233222Aygün Sterilization Container Systems2023-12-12
BR81050760061BROCA AUTOMÁTICA AYGUNClass II
SAME0000007860SFDAA00001Sterilization Container Systems
SAME0000015364SFDAA00001CONTAINER 1/1 STANDARD MODEL

Similar companies

AXERON Medical AS
Türkiye · markets 0
Bahadır Tıbbi Alet Cihaz ve İnşaat Makina San.
Türkiye · markets 2
BIÇAKÇILAR TIBBİ CİHAZLAR SAN. VE TİC. A.Ş
Türkiye · markets 2
Biomed Kardiovasküler Ürünler Ltd.Sti
Türkiye · markets 0
Boz Tibbi Malzeme Sanayi ve Ticaret A.S.
Türkiye · markets 3
Composet Medikal Malzemeler San. Tic. Ltd. Şti
Türkiye · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →