Systhex Sistemas De Implantes Ósseo Integrado Ltda
Active in EUDAMEDBrazilfrom SRN EUDAMED SRN BR-MF-000043219
- Devices
- 2,474
- Registrations
- EUDAMED
What Systhex Sistemas De Implantes Ósseo Integrado Ltda makes
The company manufactures dental implants and related components, including customizable trunnions, angled abutments, and screws for dental restoration procedures. Products include implants of varying diameters and lengths (e.g., 3.0×15.0 mm, 4.5×8.5 mm), countersink drills, and specialized abutments designed for specific anatomical angles. Additional items cover screws for universal use and hybrid implant systems without cover screws.
These devices fall under EU regulatory classifications of Class IIa and Class IIb, indicating moderate to higher-risk medical devices requiring conformity assessment. The products are registered in the EU’s eudamed database, a centralised system for medical device information. The manufacturer is based in Brazil.
Catalogue
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Company details
- EUDAMED SRN
- BR-MF-000043219
- EUDAMED status
- Active
- EUDAMED registered name
- SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA
- EUDAMED abbreviated name
- SYSTHEX IMPLANTES
- Registered address
- 586, RUA PROCÓPIO FERREIRA MARTINS, 82.940-190, CURITIBA, Brazil
- Website
- www.systhex.com.br
- linkedin.com/company/systhex
- facebook.com/systhexOficial
- [email protected]
- Phone
- +55 0800 600-6905
- PRRC contact
- Loredana Bonamigo
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 14 Dec 2030
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 755085 Active
Quality management system EU MDR
- Issued
- 5 May 2026
- Expires
- 14 Dec 2030
- Reason
- Add device or group
From the company website
With sophisticated structure and state-of-the-art technology, we offer what's best in the manufacture of Implantes Dental. Learn more here!