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Acetabular PE insert 8°, Ø 28, for cup MULTI and IGLOO size 46
EUDAMEDClass III (EU MDR)
Ref MU-DB28-46
Identity
- Device Name
- Acetabular PE insert 8°, Ø 28, for cup MULTI and IGLOO size 46 EUDAMED
- Model / Reference
- MU-DB28-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700401678156 EUDAMED
- Basic UDI-DI
- B-03700401678156 EUDAMED
- EMDN Code
- P090803040103 RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION 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
Category: Non-constrained polyethylene acetabular liner
Acetabular PE insert 8°, Ø 28, for cup MULTI and IGLOO size 46 by Biotechni S.A.S — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
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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-03700401678156 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotechni S.A.S
- EUDAMED SRN
- FR-MF-000013608
Sources (1)
- EUDAMED fa4fff4f-63d9-4f72-93d1-99fd7389cd1d 61 fields · synced Jul 26, 2026