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Cemented Hip Stem
EUDAMEDClass III (EU MDR)
Ref 130140005SRef 130110002SRef 130090000S
Identity
- Device Name
- Cemented Hip Stem EUDAMED
- Model / Reference
- 130140005S EUDAMED130110002S EUDAMED130090000S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139328632 EUDAMED06902139328601 EUDAMED06902139302052 EUDAMED
- Basic UDI-DI
- B-06902139328632 EUDAMEDB-06902139328601 EUDAMEDB-06902139302052 EUDAMED
- EMDN Code
- P090804010102 CEMENTED 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
Cemented Hip Stem 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-06902139328632 | 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 (3)
- EUDAMED 3f1bfb66-efad-4db2-8d2c-fcfd9e0205d0 61 fields · synced Sep 18, 2026
- EUDAMED 967b4062-dc80-4345-ade5-74ab04ce33f9 61 fields · synced May 16, 2026
- EUDAMED fe870069-0c5d-4ff3-b2ea-b5262772689b 61 fields · synced May 19, 2026