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Agilis
EUDAMEDClass III (EU MDR)
Ref 0758350Model AGILIS Ti-Por CUP SIZE 50 for 40 mm HEAD
Identity
- Trade Name
- AGILIS EUDAMED
- Model / Reference
- AGILIS Ti-Por CUP SIZE 50 for 40 mm HEAD EUDAMED0758350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052532833719 EUDAMED
- Basic UDI-DI
- B-08052532833719 EUDAMED
- EMDN Code
- P0908030601 PRE-ASSEMBLED ACETABULAR COMPONENTS WITH CERAMIC INSERT 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
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
Agilis by Adler Ortho S.p.A — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08052532833719 | Class III | Active |
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Manufacturer
- Manufacturer
- Adler Ortho S.p.A
- EUDAMED SRN
- IT-MF-000010164
Sources (1)
- EUDAMED 6059e23a-4e33-4f6b-997a-9b955ef2c984 61 fields · synced Oct 6, 2026