Identity
- Device Name
- Alter Cementless Hip Stem, Ti coating EUDAMED
- Model / Reference
- 130870001S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139334749 EUDAMED
- Basic UDI-DI
- B-06902139334749 EUDAMED
- EMDN Code
- P090804010202 UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Croatia 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
Alter Cementless Hip Stem, Ti coating by Double Medical Technology Inc. — 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-06902139334749 | Class III | Active |
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Manufacturer
- Manufacturer
- Double Medical Technology Inc.
- EUDAMED SRN
- CN-MF-000009048
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c545b944-979e-4d14-b536-50b953154154 61 fields · synced Jun 19, 2026