Identity
- Trade Name
- ELEC(R) EUDAMED
- Device Name
- femoral head EUDAMED
- Model / Reference
- ceramic hip implant EUDAMED110120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260436070121 EUDAMED
- Basic UDI-DI
- 426043607HPMEJ EUDAMED
- Direct Marketing DI
- 04260436070121 EUDAMED
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elec(r) by HiPer Medical AG — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426043607HPMEJ | Class III | Active |
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Manufacturer
- Manufacturer
- HiPer Medical AG
- EUDAMED SRN
- DE-MF-000008894
Sources (1)
- EUDAMED 7b312136-2b22-4eef-ad98-4a3e7dd899c7 61 fields · synced Jul 28, 2026