HomeTürkiyeVariteks Ortopedi Sanayi A.S.

Variteks Ortopedi Sanayi A.S.

Türkiye · Catalca ?Stanbul
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel — 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
pendingnot queried
USUnited StatesFDA openFDA
21listed device types
Class I 20Class II 1Class III 0
plus 21 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States21 registration records, 0 510(k), 0 PMA
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: Variteks Ortopedi Sanayi A.S. · Variteks Ortopedi Sanayi A.Ş.

Company information

Country
Türkiye
City
Catalca ?Stanbul

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 21
Orthosis, Lumbar 1Prosthesis, Breast, External, No Adhesive 1Splint, Hand, And Components 1Insoles, Medical 1Support, Hernia 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Orthosis, Sacroiliac, Soft 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000003602SFDAA00002Variteks Liposuction Garments
SAME0000003602SFDAA00004Variteks Compression stockings

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