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Surgi-Tec NV

Active in EUDAMED

Belgiumfrom SRN EUDAMED SRN BE-MF-000000257

Devices
196
Registrations
EUDAMED

What Surgi-Tec NV makes

Surgi-Tec NV manufactures orthognathic surgical hardware, including self-drilling and self-tapping screws with pentagon or round drive types, varying in diameter and length. Their portfolio also covers mandible osteotomy tools like OBA mandible devices with adjustable neck and hook configurations, as well as all-in-one patient positioning systems. Additional items include external pentagon inserts and micro screws packaged in multi-unit sets.

The company’s devices fall under EU medical device classifications, primarily Class I and Class IIb, and are registered in the EU’s eudamed database. Surgi-Tec NV is based in Belgium and adheres to EU regulatory requirements for orthognathic and orthopedic fixation products.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
BE-MF-000000257
EU VAT number
BE0461617654
EUDAMED status
Active
EUDAMED registered name
Surgi-Tec NV
EUDAMED abbreviated name
Surgi-Tec
Registered address
43, Poortakkerstraat, 9051, Sint-Denijs-Westrem, Belgium
Phone
+32 (0)92300569
PRRC contact
Suraj Susamma Sunilkumar(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 27 Nov 2029

EUDAMED certificates (1)

SGS Belgium NV 1639 1 certificate

  • BE24/00000296 Restricted

    Quality management system EU MDR

    Issued
    28 Oct 2025
    Expires
    27 Nov 2029
    Reason
    Reduce scope

From the company website

Read 18 Sep 2026

High-quality orthognathic surgery products and solutions from Surgi-Tec. We aim for precision and quality for your patients.

From the manufacturer's own website. Source