Ceramic Heads

EUDAMED

Class III (EU MDR)

Ref 0514324Model DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 EXTRA-LONG

by Adler Ortho S.p.A

Identity

Trade Name: CERAMIC HEADS EUDAMED
Model / Reference: DELTA ALUMINA CERAMIC HEAD 12/14 DIAM 32 EXTRA-LONG EUDAMED
0514324 EUDAMED

Identifiers

Primary DI / UDI-DI: 08052532831296 EUDAMED
Basic UDI-DI: B-08052532831296 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

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

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-08052532831296	Class III	Active

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Manufacturer

Manufacturer: Adler Ortho S.p.A
EUDAMED SRN: IT-MF-000010164

Sources (1)

EUDAMED 1a161342-5f02-48c4-818c-f6bbf0da60d0 61 fields · synced Oct 8, 2026