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Femoral Cruciate Substituting, Cemented, left
EUDAMEDClass III (EU MDR)
Ref 135421014S
Identity
- Device Name
- Femoral Cruciate Substituting, Cemented, left EUDAMED
- Model / Reference
- 135421014S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139343581 EUDAMED
- Basic UDI-DI
- B-06902139343581 EUDAMED
- EMDN Code
- P0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS 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
Femoral Cruciate Substituting, Cemented, left 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-06902139343581 | 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 d03f18f9-79e1-4e55-b498-a9fdd66d3ee1 61 fields · synced Jun 20, 2026