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ELEC®plus femoral head
EUDAMEDClass III (EU MDR)
Ref 726281Ref 726283Ref 726361Ref 726321Ref 726323Ref 726362Ref 726324
by ARTIQO GmbH
Identity
- Trade Name
- ELEC®plus femoral head EUDAMED
- Device Name
- Kugelkopf ELEC®plus 28 S EUDAMEDKugelkopf ELEC®plus 28 L EUDAMEDKugelkopf ELEC®plus 36 S EUDAMEDKugelkopf ELEC®plus 32 S EUDAMEDKugelkopf ELEC®plus 32 L EUDAMEDKugelkopf ELEC®plus 36 M EUDAMEDKugelkopf ELEC®plus 32 XL EUDAMED
- Model / Reference
- 726281 EUDAMED726283 EUDAMED726361 EUDAMED726321 EUDAMED726323 EUDAMED726362 EUDAMED726324 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251143405948 EUDAMED04251143405962 EUDAMED04251143406013 EUDAMED04251143405979 EUDAMED04251143405993 EUDAMED04251143406020 EUDAMED04251143406006 EUDAMED
- Basic UDI-DI
- B-04251143405948 EUDAMEDB-04251143405962 EUDAMEDB-04251143406013 EUDAMEDB-04251143405979 EUDAMEDB-04251143405993 EUDAMEDB-04251143406020 EUDAMEDB-04251143406006 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 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-04251143405948 | Class III | Active |
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Manufacturer
- Manufacturer
- ARTIQO GmbH
- EUDAMED SRN
- DE-MF-000007336
Sources (7)
- EUDAMED 9f07e33c-bc61-49d0-824c-3d75aa608909 61 fields · synced Aug 1, 2026
- EUDAMED 1860965a-b288-4977-a437-4787581b8f7f 61 fields · synced May 17, 2026
- EUDAMED 7a70d6b8-e833-4237-9ff0-f83492b78a36 61 fields · synced May 17, 2026
- EUDAMED 63e02b9a-3013-49a4-82fb-a0a7129d9b51 61 fields · synced May 18, 2026
- EUDAMED 0f00d674-cca7-4ffd-a9a3-9b22ffd9de03 61 fields · synced May 18, 2026
- EUDAMED d2694f04-1d1a-4ddd-bc16-81e11f8968be 61 fields · synced May 18, 2026
- EUDAMED 2d319f21-6a9e-47c0-9609-e4162660ae13 61 fields · synced May 19, 2026