Cemex Genta Hv Gamma
Ref 1400/IG INT
Active
CE MDR
Valid until
16 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number80314970111N8 28031497001344 | Date8 May 2026 | StatusActive |
Certificates
- MDR 738112 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 19 Feb 2026
- Expires
- 16 Jan 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cemex Genta
- Model / Reference
- 1400/IG INT
- Primary DI / UDI-DI
- 28031497001344
- Basic UDI-DI
- 80314970111N8
- EMDN Code
- P099001 Orthopaedic prostheses cements and accessories for mixing
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000027512
Other devices from Tecres S.p.A.
Properties
Other properties (8)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No