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Bipolar Acetabular Cup
EUDAMEDClass III (EU MDR)
Ref 130020054SRef 130020042SRef 130020058SRef 130020046SRef 130020056SRef 130020048S
Identity
- Device Name
- Bipolar Acetabular Cup EUDAMED
- Model / Reference
- 130020054S EUDAMED130020042S EUDAMED130020058S EUDAMED130020046S EUDAMED130020056S EUDAMED130020048S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139301826 EUDAMED06902139301765 EUDAMED06902139301840 EUDAMED06902139301789 EUDAMED06902139301833 EUDAMED06902139301796 EUDAMED
- Basic UDI-DI
- B-06902139301826 EUDAMEDB-06902139301765 EUDAMEDB-06902139301840 EUDAMEDB-06902139301789 EUDAMEDB-06902139301833 EUDAMEDB-06902139301796 EUDAMED
- EMDN Code
- P0908040503 HIP PROSTHESES, BI-ARTICULAR CUPS 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
Bipolar Acetabular Cup 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-06902139301826 | 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 (6)
- EUDAMED 64830fa7-46f2-4834-8cd7-6fe6b3a5828b 61 fields · synced Sep 17, 2026
- EUDAMED 2b3003fc-2181-4fae-a912-de1fd84e9d87 61 fields · synced May 16, 2026
- EUDAMED b9e51760-c1d1-4968-bc92-f44dce322c57 61 fields · synced May 17, 2026
- EUDAMED c544865a-0a04-42ca-8711-769a03a52da0 61 fields · synced May 18, 2026
- EUDAMED f1193b79-8467-4b5e-a996-d54b7b753887 61 fields · synced May 18, 2026
- EUDAMED 0f5d838d-739a-4bc3-a057-2903b9271cb8 61 fields · synced May 18, 2026