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Liner PE
EUDAMEDClass III (EU MDR)
Ref BO76.1794.000.00Model Liner PE Standard D.32 D
Identity
- Device Name
- Liner PE EUDAMED
- Model / Reference
- Liner PE Standard D.32 D EUDAMEDBO76.1794.000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050507911066 EUDAMED
- Basic UDI-DI
- B-08050507911066 EUDAMED
- Direct Marketing DI
- 08050507911066 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 PE by Lincotek Bologna S.r.l — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
- RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
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- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- 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-08050507911066 | Class III | Active |
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Manufacturer
- Manufacturer
- Lincotek Bologna S.r.l
- EUDAMED SRN
- IT-MF-000033944
Sources (1)
- EUDAMED d2585564-b679-4825-9cb5-c1184e571591 61 fields · synced Jun 18, 2026