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Ceramic Heads
EUDAMEDClass III (EU MDR)
Ref 0514442Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 44 MEDIUM
Identity
- Trade Name
- CERAMIC HEADS EUDAMED
- Model / Reference
- DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 44 MEDIUM EUDAMED0514442 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052532831395 EUDAMED
- Basic UDI-DI
- B-08052532831395 EUDAMED
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Ceramic Heads by Adler Ortho S.p.A — Class III — CE/MDR — 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-08052532831395 | Class III | Active |
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Manufacturer
- Manufacturer
- Adler Ortho S.p.A
- EUDAMED SRN
- IT-MF-000010164
Sources (1)
- EUDAMED 962dd0c2-68b5-4036-a6ef-2039c76e8827 61 fields · synced Oct 8, 2026