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Variteks Medikal Sanayi Ve Ticaret A.S.

Türkiye·TR-MF-000048979

Last updated September 17, 2026

About

Founded in 1958 by Nimet Öztürkatalay, the Standard Korstex Medical and Sanitary Wares and Variteks Ortopedi Sanayi A.Ş, which joined the group in 1985, has become the leading company in Turkey with its continuous developing structure without sacrificing quality since its foundation. Our story started by making our first corset in a small workshop is now located in Istanbul Thrace Free Zone and continues with our modern facilities, experienced expert staff and up-to-date corporate structure in our factory. In our factory that provides the highest level of efficiency in the production with architecture, we also take the efficiency in the energy required by our world. Our building has been the first factory certified by the green building of Turkey in medical device production facilities. This situation we add responsibility as social and human is also supporting the sustainability of the quality product balance, which is our policy since the other. We are aware that the product we produce is medical devices. The system and product standards in our factory are followed by a great care of the registration processes and traceability process required by social standards. Our satisfaction is not only about the satisfaction of our customers in more than 80 countries in Turkey and exports. All you need is to get to our products; everyone who uses is happy. We are aware of the responsibility of being the first exporter of Turkey in Turkey. With the power we have received from our past experience and story, investments we do today are our trust source for tomorrow. We continue to relax and improve the movement with comfort. You must continue without giving up!..

Translated from the manufacturer's own website. Source

What Variteks Medikal Sanayi Ve Ticaret A.S. makes

The company manufactures prefabricated orthotic insoles without antimicrobial properties, ankle/foot orthoses, and reusable compression/pressure socks or stockings. It also produces silicone breast prostheses in pear-shaped designs, bras designed to support breast prostheses, metal foot supports, silicone insoles with arch support, silicone full-length insoles, and pediatric walking boots in small sizes.

All devices fall under EU Class I regulation and are listed in the EUDAMED registry. The manufacturer is based in Turkey.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Variteks Medikal Sanayi Ve Ticaret A.S. manufacture?

Variteks Medikal Sanayi Ve Ticaret A.S. specializes in Class I medical devices, including prefabricated orthotic insoles (without antimicrobial properties), ankle and foot orthoses, and reusable compression or pressure socks/stockings. Additionally, they produce silicone breast prostheses in pear-shaped designs, bras designed to support these prostheses, metal foot supports, silicone insoles with arch support, silicone full-length insoles, and pediatric walking boots in small sizes. These products are designed to support mobility, comfort, and medical needs.

Where is Variteks Medikal Sanayi Ve Ticaret A.S. based?

The company is based in Turkey, operating from its facility in the Istanbul Thrace Free Zone. This location supports its manufacturing and export operations, allowing it to supply devices to markets globally.

Are the devices manufactured by Variteks Medikal Sanayi Ve Ticaret A.S. listed in any regulatory registries?

Yes, the devices produced by Variteks Medikal Sanayi Ve Ticaret A.S. are listed in the EUDAMED registry. This platform is used to track and provide transparency on medical devices authorized within the European Union, ensuring regulatory oversight and compliance.

How are the devices manufactured by Variteks Medikal Sanayi Ve Ticaret A.S. classified under EU regulations?

All devices manufactured by Variteks Medikal Sanayi Ve Ticaret A.S. fall under EU Class I classification. This classification applies to low-risk medical devices, such as orthotics, compression garments, and certain prostheses, which require less stringent regulatory scrutiny compared to higher-risk categories.

What reasoning determines why Variteks Medikal Sanayi Ve Ticaret A.S. devices are classified as Class I?

The classification of Variteks Medikal Sanayi Ve Ticaret A.S. devices as Class I is based on their intended use and associated risk levels. Devices like prefabricated orthotic insoles, ankle/foot orthoses, compression socks, silicone prostheses, and pediatric walking boots are considered low-risk because they do not invade the body, do not rely on electrical power, and pose minimal risk of injury or adverse effects when used as directed. EU regulations categorize such devices as Class I due to their limited interaction with the body and predictable safety profiles.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Türkiye
Address
Ferhatpaşa Mah. Çatalca Yolu Cad. No: 27/3 İç Kapı No:Z1 Çatalca/İSTANBUL, İstanbul, Türkiye
Phone
+90 212 544 30 50
PRRC Contact
Bedri Okan ÖZTÜRKATALAY
EUDAMED SRN
TR-MF-000048979
FDA FEI Number
—
DUNS Number
—

Catalogue (130)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Metal Foot Support No:28 501
EUDAMED
Class IActive
Silicone Breast Prothesis (Pear - Symmetrial) No: 125 570
EUDAMED
Class IActive
Metal Foot Support No:24 501
EUDAMED
Class IActive
Bra For Breast Prothesis No: 90 577
EUDAMED
Class IActive
Silicone Breast Prothesis (Pear - Symmetrial) No: 100 570
EUDAMED
Class IActive
Bra For Breast Prothesis No: 95 577
EUDAMED
Class IActive
Bra For Breast Prothesis No: 60 577
EUDAMED
Class IActive
Pediatric Walking Boot - S 811
EUDAMED
Class IActive
Metal Foot Support No:42 501
EUDAMED
Class IActive
Silicone Insole With Arch Support - XS 541
EUDAMED
Class IActive
Silicone Full Lenght Insole - XS 542
EUDAMED
Class IActive
Metal Foot Support No:45 501
EUDAMED
Class IActive
Silicone Full Lenght Insole - S 542
EUDAMED
Class IActive
Support Collar No: 2 201
EUDAMED
Class IActive
Silicone Toe Crest With Loop (Standard - Right) 553
EUDAMED
Class IActive
Silicone Heel Spur - M 544
EUDAMED
Class IActive
Chin Support Collar No: 3 202
EUDAMED
Class IActive
Metal Foot Support No:26 501
EUDAMED
Class IActive
Metal Foot Support No:30 501
EUDAMED
Class IActive
Air-Cushioned Walking Boot (Short) - XL 812
EUDAMED
Class IActive
Hip Abduction Orthosis No: 5 188
EUDAMED
Class IActive
Silicone Insole With Arch Support - M 541
EUDAMED
Class IActive
Silicone Breast Prothesis (Pear - Symmetrial) No: 80 570
EUDAMED
Class IActive
Silicone Toe Cap - S 548
EUDAMED
Class IActive
Silicone Full Lenght Insole - XL 542
EUDAMED
Class IActive
Bra For Breast Prothesis No: 120 577
EUDAMED
Class IActive
Bra For Breast Prothesis No: 110 577
EUDAMED
Class IActive
Air-Cushioned Walking Boot (Standard) - S 813
EUDAMED
Class IActive
Air-Cushioned Walking Boot (Standard) - XL 813
EUDAMED
Class IActive
Silicone Heel Spur - S 594
EUDAMED
Class IActive
Bra For Breast Prothesis No: 75 577
EUDAMED
Class IActive
Silicone Breast Prothesis (Pear - Symmetrial) No: 85 570
EUDAMED
Class IActive
Support Collar No: 4 201
EUDAMED
Class IActive
Silicone Toe Spreader - M 545
EUDAMED
Class IActive
Bra For Breast Prothesis No: 130 577
EUDAMED
Class IActive
Metal Foot Support No:41 501
EUDAMED
Class IActive
Silicone Hand Rehabilitation Ball - Soft / Green 560
EUDAMED
Class IActive
Metal Foot Support No:22 501
EUDAMED
Class IActive
Silicone Toe Spreader - L 545
EUDAMED
Class IActive
Silicone Breast Prothesis (Pear - Symmetrial) No: 105 570
EUDAMED
Class IActive
Silicone Ring - S 547
EUDAMED
Class IActive
Silicone Heel Spur - M 594
EUDAMED
Class IActive
Chin Support Collar No: 4 202
EUDAMED
Class IActive
Elastic Bandage 8cm X 2m 408
EUDAMED
Class IActive
Metal Foot Support No:21 501
EUDAMED
Class IActive
Hip Abduction Orthosis No: 3 188
EUDAMED
Class IActive
Metal Foot Support No:33 501
EUDAMED
Class IActive
Silicone Full Lenght Insole - M 542
EUDAMED
Class IActive
Silicone Hand Rehabilitation Ball - Hard / Red 560
EUDAMED
Class IActive
Bra For Breast Prothesis No: 115 577
EUDAMED
Class IActive

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