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Insert XLfit PE réticulé + vitamine E 0° diam. 40 mm (ZZ)
EUDAMEDClass III (EU MDR)
Ref 16-16-40-ZZModel insert XLFIT PE réticulé
Identity
- Trade Name
- Insert XLfit PE réticulé + vitamine E 0° diam. 40 mm (ZZ) EUDAMED
- Device Name
- XLFIT crosslinked PE insert EUDAMED
- Model / Reference
- insert XLFIT PE réticulé EUDAMED16-16-40-ZZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- EPRS161640ZZA0 EUDAMED
- Basic UDI-DI
- B-EPRS161640ZZA0 EUDAMED
- EMDN Code
- P090803040101 STANDARD POLYETHYLENE HIP PROSTHESES 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
Category: Non-constrained polyethylene acetabular liner
Insert XLfit PE réticulé + vitamine E 0° diam. 40 mm (ZZ) by Protheos Industrie — 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-EPRS161640ZZA0 | Class III | Active |
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Manufacturer
- Manufacturer
- Protheos Industrie
- EUDAMED SRN
- FR-MF-000000150
Sources (1)
- EUDAMED 1d9c5744-63b4-47e4-bc8f-0c0ed9ace631 61 fields · synced Jul 10, 2026