ELEC(R)plus
by HiPer Medical AG 77 variants
Ref 160130Model ceramic hip implant
Active
CE MDR
Valid until
8 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number12970GB450250320 | Date20 Mar 2025 | StatusActive |
Certificates
- 12970GB450250320 Active
Technical documentation EU MDR
- Certifier
- DNV MEDCERT GmbH 0482
- Issued
- 20 Mar 2025
- Expires
- 8 Jan 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- femoral head
- Model / Reference
- ceramic hip implant, 160130
- Primary DI / UDI-DI
- 04260436073139
- Basic UDI-DI
- 426043607HPMEJ
- Direct Marketing DI
- 04260436073139
- EMDN Code
- P0908040504 Revision femoral heads
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000008894
Other devices from HiPer Medical AG
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No