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Apta-Fix Stem
EUDAMEDClass III (EU MDR)
Ref 0181615Model APTA-FIX ANATOMICAL CEMENTED STEM NECK 12/14 M30 STANDARD SIZE 5 LEFT
Identity
- Trade Name
- APTA-FIX STEM EUDAMED
- Model / Reference
- APTA-FIX ANATOMICAL CEMENTED STEM NECK 12/14 M30 STANDARD SIZE 5 LEFT EUDAMED0181615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050880235797 EUDAMED
- Basic UDI-DI
- B-08050880235797 EUDAMED
- EMDN Code
- P090804010102 CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL 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
Apta-Fix Stem 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-08050880235797 | Class III | Active |
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Manufacturer
- Manufacturer
- Adler Ortho S.p.A
- EUDAMED SRN
- IT-MF-000010164
Sources (1)
- EUDAMED b0b8ebad-0e11-4870-bb23-0c22ab32da54 61 fields · synced Aug 4, 2026