A28110301

EUDAMED

Class III (EU MDR)

Ref A28110301Model Tête fémorale BIOLOX®delta – ø36mm – Col S / -4mm – Cône 12/14

by Euros Sas

Identity

Model / Reference: Tête fémorale BIOLOX®delta – ø36mm – Col S / -4mm – Cône 12/14 EUDAMED
A28110301 EUDAMED

Identifiers

Primary DI / UDI-DI: 03700437204060 EUDAMED
Basic UDI-DI: B-03700437204060 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

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Ceramic femoral head prosthesis

A28110301 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-03700437204060	Class III	Active

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Manufacturer

Manufacturer: Euros Sas
EUDAMED SRN: FR-MF-000000605

Sources (1)

EUDAMED fdba53ad-a9bd-451f-a2e6-745aa32222ff 61 fields · synced Jun 18, 2026