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A28110201
EUDAMEDClass III (EU MDR)
Ref A28110201Model Tête fémorale BIOLOX®delta – ø32mm – Col S / -4mm – Cône 12/14
by Euros Sas
Identity
- Trade Name
- Têtes fémorales EUDAMED
- Model / Reference
- Tête fémorale BIOLOX®delta – ø32mm – Col S / -4mm – Cône 12/14 EUDAMEDA28110201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700437204022 EUDAMED
- Basic UDI-DI
- B-03700437204022 EUDAMED
- EMDN Code
- P090804050201 CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France 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
Category: Ceramic femoral head prosthesis
A28110201 by Euros Sas — 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-03700437204022 | Class III | Active |
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Manufacturer
- Manufacturer
- Euros Sas
- EUDAMED SRN
- FR-MF-000000605
Sources (2)
- EUDAMED fbec5332-3325-4791-a773-c1af8e0fb0a7 61 fields · synced Jul 8, 2026
- EUDAMED 160f6519-2f7a-4421-b58b-8e55a753210f 61 fields · synced Jul 8, 2026