Identity
- Trade Name
- ACORN Primary: Trial Cup Ø 40mm EUDAMED
- Device Name
- Trial Component EUDAMED
- Model / Reference
- S38640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323081851 EUDAMED
- Basic UDI-DI
- B-08050323081851 EUDAMED
- EMDN Code
- V06010101 HIP PROSTHESES TESTING DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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: Acetabulum prosthesis trial, prefabricated, reusable
ACORN Primary: Trial Cup Ø 40mm by Permedica S.p.A — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08050323081851 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (2)
- EUDAMED 73a7fd73-7e6b-426f-9bac-8b42c989d517 61 fields · synced Jul 9, 2026
- EUDAMED 462d8614-6613-4e1b-a4ca-90b8c83558a7 61 fields · synced Jul 9, 2026