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ELEC®plus Revision - femoral head
EUDAMEDClass III (EU MDR)
Ref 727323Ref 727282Ref 727284Ref 727322
by ARTIQO GmbH
Identity
- Trade Name
- ELEC®plus Revision - femoral head EUDAMED
- Device Name
- Kugelkopf ELEC®plus Revision 32 L EUDAMEDKugelkopf ELEC®plus Revision 28 M EUDAMEDKugelkopf ELEC®plus Revision 28 XL EUDAMEDKugelkopf ELEC®plus Revision 32 M EUDAMED
- Model / Reference
- 727323 EUDAMED727282 EUDAMED727284 EUDAMED727322 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251143406112 EUDAMED04251143406068 EUDAMED04251143406082 EUDAMED04251143406105 EUDAMED
- Basic UDI-DI
- B-04251143406112 EUDAMEDB-04251143406068 EUDAMEDB-04251143406082 EUDAMEDB-04251143406105 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ceramic femoral head prosthesis
ELEC®plus Revision - femoral head by ARTIQO GmbH — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04251143406112 | Class III | Active |
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Manufacturer
- Manufacturer
- ARTIQO GmbH
- EUDAMED SRN
- DE-MF-000007336
Sources (4)
- EUDAMED c5d862c5-d5c8-4208-a575-496758c5c438 61 fields · synced Jul 30, 2026
- EUDAMED 49156400-98e2-47b1-90db-973e2e0f470e 61 fields · synced May 18, 2026
- EUDAMED 68732892-51a1-4166-820a-9b3c563a60ec 61 fields · synced May 18, 2026
- EUDAMED 363f2b71-38b6-4ced-ae18-66bd82121318 61 fields · synced May 18, 2026