Biolox Delta alumina insert (18°) Ø28, for MULTI and IGLOO18° cup S48-50

EUDAMED

Class III (EU MDR)

Ref ICERAM28-39

by Biotechni S.A.S

Identity

Device Name: Biolox Delta alumina insert (18°) Ø28, for MULTI and IGLOO18° cup S48-50 EUDAMED
Model / Reference: ICERAM28-39 EUDAMED

Identifiers

Primary DI / UDI-DI: 03700401609785 EUDAMED
Basic UDI-DI: B-03700401609785 EUDAMED
EMDN Code: P0908030402 HIP PROSTHESES CERAMIC ACETABULAR INSERTS 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

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Biolox Delta alumina insert (18°) Ø28, for MULTI and IGLOO18° cup S48-50 by Biotechni S.A.S — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS

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-03700401609785	Class III	Active

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Manufacturer

Manufacturer: Biotechni S.A.S
EUDAMED SRN: FR-MF-000013608

Sources (1)

EUDAMED 21aee63f-c39b-46d5-b8cc-54a8ee4b6573 61 fields · synced Jun 19, 2026