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Ceramic Femoral Head
EUDAMEDClass III (EU MDR)
Ref 130653604SRef 130643204SRef 130653603SRef 130654004SRef 130632803SRef 130632802SRef 130632801SRef 130653601SRef 130654003SRef 130654001S
Identity
- Device Name
- Ceramic Femoral Head EUDAMED
- Model / Reference
- 130653604S EUDAMED130643204S EUDAMED130653603S EUDAMED130654004S EUDAMED130632803S EUDAMED130632802S EUDAMED130632801S EUDAMED130653601S EUDAMED130654003S EUDAMED130654001S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139329370 EUDAMED06902139330581 EUDAMED06902139329363 EUDAMED06902139386816 EUDAMED06902139329301 EUDAMED06902139329622 EUDAMED06902139329615 EUDAMED06902139329349 EUDAMED06902139386809 EUDAMED06902139386786 EUDAMED
- Basic UDI-DI
- B-06902139329370 EUDAMEDB-06902139330581 EUDAMEDB-06902139329363 EUDAMEDB-06902139386816 EUDAMEDB-06902139329301 EUDAMEDB-06902139329622 EUDAMEDB-06902139329615 EUDAMEDB-06902139329349 EUDAMEDB-06902139386809 EUDAMEDB-06902139386786 EUDAMED
- EMDN Code
- P090804050201 CERAMIC 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: Ceramic femoral head prosthesis
Ceramic Femoral Head by Double Medical Technology Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · 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-06902139329370 | 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 (10)
- EUDAMED 27da4214-d6de-428c-b387-fccff4a770cd 61 fields · synced Jul 28, 2026
- EUDAMED 66fe544a-6920-434c-8a10-e56d5f3b8b7d 61 fields · synced May 16, 2026
- EUDAMED 9bdfb3b5-913c-4755-ac3b-bdd75cf35600 61 fields · synced May 16, 2026
- EUDAMED 5a96fe87-5b34-4f63-99ce-889fe8a89850 61 fields · synced May 17, 2026
- EUDAMED 87cdeb41-2edd-4f3a-84a9-a98cfdba6017 61 fields · synced May 17, 2026
- EUDAMED f1b6f4d9-569b-4203-8b89-044c644946ae 61 fields · synced May 17, 2026
- EUDAMED 47bdeed9-a68b-4a92-98b4-26137169fc41 61 fields · synced May 17, 2026
- EUDAMED 1f8ed37e-dfae-47b2-8811-54eb638805cc 61 fields · synced May 18, 2026
- EUDAMED 641dba5d-5898-4612-b7b6-967c64d7ed41 61 fields · synced May 18, 2026
- EUDAMED b1a266f0-c7a3-4199-b15a-718c98f4c715 61 fields · synced May 19, 2026