Identity
- Device Name
- Ceramic Acetabular Liner EUDAMED
- Model / Reference
- 130460050S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139380920 EUDAMED
- Basic UDI-DI
- B-06902139380920 EUDAMED
- EMDN Code
- P0908030402 HIP PROSTHESES CERAMIC ACETABULAR INSERTS 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
Ceramic Acetabular Liner 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-06902139380920 | 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 e9f324f2-914f-4a8c-bbc2-2b9239730458 61 fields · synced Jun 19, 2026