Surgi-Tec NV
Active in EUDAMEDBelgiumfrom SRN EUDAMED SRN BE-MF-000000257
- Devices
- 196
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
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.
Catalogue
Search and filter all 196 devicesShowing 1-50 of 196
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
- Website
- www.surgi-tec.com
- [email protected]
- Phone
- +32 (0)92300569
- PRRC contact
- Suraj Susamma Sunilkumar
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 27 Nov 2029
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
High-quality orthognathic surgery products and solutions from Surgi-Tec. We aim for precision and quality for your patients.
Frequently asked questions
How many devices does Surgi-Tec NV have in the registry?
The registry currently lists 196 devices for Surgi-Tec NV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgi-Tec NV's devices?
Among its 50 most recently registered devices, Surgi-Tec NV has devices listed in EUDAMED (50 devices).
What risk classes do Surgi-Tec NV's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Surgi-Tec NV's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Surgi-Tec NV?
EUDAMED lists 1 certificate for Surgi-Tec NV (quality management system) under MDR. The most recent was issued on 28 Oct 2025.
What are the newest devices from Surgi-Tec NV in the registry?
The most recently registered devices listed for Surgi-Tec NV include Ø 2.0 Selfdrilling Screw - L 9 mm - Pentagon, Ø 1.2 Selftapping Micro Screw - L 5 mm - Pentagon, Ø 2.3 Selftapping Screw - L 15 mm - low Pentagon - STERILE and OBA Mandible - Long neck - Long hook - Left.