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Alter Cementless Hip Stem, Ti coating
EUDAMEDClass III (EU MDR)
Ref 130870006SRef 130870007SRef 130870004SRef 130870003SRef 130870005S
Identity
- Device Name
- Alter Cementless Hip Stem, Ti coating EUDAMED
- Model / Reference
- 130870006S EUDAMED130870007S EUDAMED130870004S EUDAMED130870003S EUDAMED130870005S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139334794 EUDAMED06902139334800 EUDAMED06902139334770 EUDAMED06902139334763 EUDAMED06902139334787 EUDAMED
- Basic UDI-DI
- B-06902139334794 EUDAMEDB-06902139334800 EUDAMEDB-06902139334770 EUDAMEDB-06902139334763 EUDAMEDB-06902139334787 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-06902139334794 | 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 (5)
- EUDAMED 00ecfb15-9186-4f60-9ecc-929bae88e0dc 61 fields · synced Jul 27, 2026
- EUDAMED 4e820967-2f0c-4edf-a054-d3c1805a9aea 61 fields · synced May 17, 2026
- EUDAMED 74d056f8-a353-4f9d-94bb-72446be5f0d4 61 fields · synced May 18, 2026
- EUDAMED 16803f63-0e5a-436e-a665-348171dd0fc6 61 fields · synced May 18, 2026
- EUDAMED 7c67c93c-8f3d-412c-b0b4-8cc0a167587a 61 fields · synced May 18, 2026