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Femoral Head
EUDAMEDClass III (EU MDR)
Ref 130910002SRef 130010008SRef 130910009SRef 130010001SRef 130910001S
Identity
- Device Name
- Femoral Head EUDAMED
- Model / Reference
- 130910002S EUDAMED130010008S EUDAMED130910009S EUDAMED130010001S EUDAMED130910001S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139330598 EUDAMED06902139301734 EUDAMED06902139313751 EUDAMED06902139301710 EUDAMED06902139313737 EUDAMED
- Basic UDI-DI
- B-06902139330598 EUDAMEDB-06902139301734 EUDAMEDB-06902139313751 EUDAMEDB-06902139301710 EUDAMEDB-06902139313737 EUDAMED
- EMDN Code
- P090804050202 METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT 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
Category: Metallic femoral head prosthesis
Femoral Head by Double Medical Technology Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Metallic femoral head prosthesis.
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- Orthinox — Howmedica Osteonics Corp. · Class II
- A110212031 — EUROS SAS · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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-06902139330598 | 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 cf21e06a-64b0-4f55-af2c-7b86fe0a7760 61 fields · synced Jul 20, 2026
- EUDAMED cc053e2c-d071-4776-99e8-4d479252ac02 61 fields · synced May 17, 2026
- EUDAMED f529c4a2-2b89-49c9-8337-17a48eaf81bf 61 fields · synced May 18, 2026
- EUDAMED e8353e5c-442f-43d9-b106-306aa07c22f4 61 fields · synced May 18, 2026
- EUDAMED 1f0a4b39-d946-4fed-945b-6988d4335e3c 61 fields · synced May 19, 2026