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Liner X-PE
EUDAMEDClass III (EU MDR)
Ref BO76.1817.000.00Model Liner X-PE Standard D.22 G
Identity
- Device Name
- Liner X-PE EUDAMED
- Model / Reference
- Liner X-PE Standard D.22 G EUDAMEDBO76.1817.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050507911295 EUDAMED
- Basic UDI-DI
- B-08050507911295 EUDAMED
- Direct Marketing DI
- 08050507911295 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES INSERTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Non-constrained polyethylene acetabular liner
Liner X-PE by Lincotek Bologna S.r.l — 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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- PINNACLE — DEPUY ORTHOPAEDICS, INC. · 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-08050507911295 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (1)
- EUDAMED 3b2b27f0-7428-4b98-a4f9-4ee06759f51f 61 fields · synced Jun 19, 2026