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Biolox Delta alumina insert (18°) Ø28 , for MULTI and IGLOO18° cup S58 to S69
EUDAMEDClass III (EU MDR)
Ref ICERAM28-48
Identity
- Device Name
- Biolox Delta alumina insert (18°) Ø28 ,for MULTI and IGLOO18° cup S58 to S69 EUDAMED
- Model / Reference
- ICERAM28-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700401609808 EUDAMED
- Basic UDI-DI
- B-03700401609808 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
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
Biolox Delta alumina insert (18°) Ø28 , for MULTI and IGLOO18° cup S58 to S69 by Biotechni S.A.S — Class III — MDD — listed in EUDAMED
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-03700401609808 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotechni S.A.S
- EUDAMED SRN
- FR-MF-000013608
Sources (1)
- EUDAMED 4787a27a-f0ee-4112-9ea7-a57266af2067 61 fields · synced Jun 20, 2026