Systhex Sistemas De Implantes Ósseo Integrado Ltda
Active in EUDAMEDBrazilfrom SRN EUDAMED SRN BR-MF-000043219
- Devices
- 2,474
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Sbp Portugal LdaPT
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
Search and filter all 2,474 devicesShowing 1-50 of 2,474
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!
Frequently asked questions
How many devices does SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA have in the registry?
The registry currently lists 2474 devices for SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA. Devices recorded under merged duplicate company entries are counted once.
Which registries list SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA's devices?
Among its 50 most recently registered devices, SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA has devices listed in EUDAMED (50 devices).
What risk classes do SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA?
EUDAMED lists 1 certificate for SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA (quality management system) under MDR. The most recent was issued on 5 May 2026.
What are the newest devices from SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA in the registry?
The most recently registered devices listed for SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA include Sinus Lift Curette n° 6, Connection for Torque Wrench CI 3.3mm Short, Connection for Torque Wrench Attos Medium and Connection for Torque Wrench IN CR 3.6mm Long.