Corporate

OEM Sterile Surgical Drape & Gown Manufacturer in Turkey

HS codes, commercial terms and distributorship information on a single page.

Tio Medikal has been exporting to 45 countries since 2011.

Turkey's location between Europe and the Middle East means shorter shipping times by sea and land compared to manufacturers based in East Asia. Our products are certified under EU Medical Device Regulation 2017/745 (CE MDR), a direct regulatory fit for European buyers.

Here we have gathered the commercial and customs information most frequently asked by our distributors and export partners. For information not yet added to this page, such as production lead time, you can contact us directly.

HS Codes

Surgical Drapes and Sets: 6307.90.92.00.00
Surgical Gowns: 6210.10.92.00.00

Commercial Terms

Minimum Order (Sets): 100 pcs
Minimum Order (Drapes / Gowns): 1,000 pcs
Samples: Free of charge
Delivery Terms (Incoterms): EXW
Private Label Minimum: 10,000 pcs

Our Certifications

EN 13795: 185794-TSE-01/03 · Türk Standardları Enstitüsü (TSE) · valid until: 2026-12-31
ISO 13485: TC-75750 · CAC Conformity Assessment Center d.o.o. (Hırvatistan); sistem sertifikasyon onayı: PCA Sertifikasyon Hizmetleri Ltd. Şti. (Türkiye), IAF/IAS akreditasyonlu (MSCB-103) · valid until: 2027-07-24
CE: M.2022.MDR.1009 · UDEM Adriatic d.o.o., Onaylanmış Kuruluş No: 2696 (AB Tıbbi Cihaz Yönetmeliği 2017/745 kapsamında) · valid until: 2027-12-18

Registration and Compliance

Thanks to our MDR certification, we hold a current registration in the EU EUDAMED system. Product registration status for other markets is confirmed separately according to the target country.

Distributorship

For region-based exclusive distributorship, the annual minimum turnover target is determined jointly, based on the target market.

Fabric and Test Data

Our surgical drapes are manufactured from 54 gsm Doubleflex absorbent fabric, and our surgical gowns from 40 gsm SSMMS fabric; different raw material options are also available. All performance test reports, including hydrostatic pressure and bacterial penetration, are shared upon request.

Sample and Quote Process

Fill out the quote form or reach us on WhatsApp.
Request a free sample and evaluate the product against your own standards.
After evaluation, proceed to an order or a distributorship discussion.

Frequently Asked Questions

What is the minimum order quantity for private label surgical drapes?

The minimum order for private label production is 10,000 pieces.

Do you offer free samples?

Yes, samples are provided free of charge.

What are your delivery terms?

Our standard delivery term is EXW (Incoterms).

Are your products CE MDR and ISO 13485 certified?

Yes. See our ISO 13485 (TC-75750) and CE MDR (M.2022.MDR.1009) certificates.

Is there a difference in minimum order between sterile sets and drapes/gowns?

Yes. The minimum order is 100 pieces for sterile sets and 1,000 pieces for drapes/gowns.