Surgi-Tec NV
BE-MF-000000257 · Belgium · Sint-Denijs-Westrem
Surgi-Tec NV is registered in the European database on medical devices as a manufacturer, with 242 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 227 |
|---|---|
| Class IIa | 15 |
Among these devices, 113 are declared sterile, 227 implantable, 10 reusable.
Devices declared under this manufacturer
- OBA Maxilla - Long neck - Straight hook - Right STERILE
- Slot Plate - SLA - Emerald
- Ø 1.2 Selftapping Micro Screw - L 15 mm - Pentagon
- Ø 1.2 Selftapping Micro Screw - L 15 mm - Pentagon - 5 Pack
- Ø 1.2 Selftapping Micro Screw - L 15 mm - Pentagon - 5 Pack STERILE
- Ø 1.2 Selftapping Micro Screw - L 17 mm - Pentagon - 5 Pack STERILE
- Ø 1.2 Selftapping Micro Screw - L 9 mm - Pentagon - 5 Pack STERILE
- Ø 1.8 Selftapping screw - L 5 mm - Round - 5 Pack STERILE
- Ø 2.0 Selfdrilling Screw - L 7 mm - Pentagon - 2 Pack STERILE
- Ø 2.0 Selfdrilling Screw - L 7 mm - Round
- Ø 2.0 Selftapping Screw - L 7 mm - Round - 5 Pack
- Ø 2.3 Selftapping Screw - L 21 mm - low Pentagon - 5 Pack STERILE
Showing 12 of 242 declared devices.
Catalogue references include 02-024S - STER, 60-004S, 70-105S, 70-209S.5 - STER, 70-607S.5, 70-707S.2 - STER.
European nomenclature codes declared: P01020101, L26, V9099, L99, Z12110199, L030199.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | Surgitech, Inc. (US) · FDA 2032724 |
| Devices in EUDAMED | 242 |
| Country of registration | Belgium |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 242 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
BE24/00000296 | restricted | 2029-11-27 |