ELEC(R)plus
by HiPer Medical AG 77 variants
Part of a family of 91 devices: see the family page
Ref 110260Model ceramic hip implant
ELEC(R)plus (110260) is a Class III device made by HiPer Medical AG, registered in EUDAMED on 8 Nov 2024 (Basic UDI-DI 426043607HPMEJ) with CE/MDR certificate 12970GB450250320 valid until 8 Jan 2028, active as of 23 Oct 2026.
Active
CE MDR
Valid until
8 Jan 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number12970GB450250320 | Date20 Mar 2025 | StatusActive |
Official records
- EUDAMED public site 426043607HPMEJ
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
Timeline
- Registered EUDAMED 426043607HPMEJ
- Certificate issued EUDAMED 12970GB450250320
- Certificate expires EUDAMED 12970GB450250320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- femoral head
- Model / reference
- ceramic hip implant, 110260
- Primary DI / UDI-DI
- 04260436071036
- Basic UDI-DI
- 426043607HPMEJ
- Direct marketing DI
- 04260436071036
- EMDN code
- P090804050201 Ceramic femoral heads, total hip replacement
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000008894
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