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Bone Screw
EUDAMEDClass III (EU MDR)
Ref 130070024SRef 130070026SRef 130070038SRef 130070028SRef 130070040S
Identity
- Device Name
- Bone Screw EUDAMED
- Model / Reference
- 130070024S EUDAMED130070026S EUDAMED130070038S EUDAMED130070028S EUDAMED130070040S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902139301871 EUDAMED06902139301888 EUDAMED06902139301949 EUDAMED06902139301895 EUDAMED06902139301956 EUDAMED
- Basic UDI-DI
- B-06902139301871 EUDAMEDB-06902139301888 EUDAMEDB-06902139301949 EUDAMEDB-06902139301895 EUDAMEDB-06902139301956 EUDAMED
- EMDN Code
- P09088007 HIP PROSTHESES FIXING SCREWS 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: Orthopaedic bone screw (non-sliding)
Bone Screw by Double Medical Technology Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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-06902139301871 | 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 df843f69-c1d8-49b8-a1fa-4cc858c9a137 61 fields · synced Aug 1, 2026
- EUDAMED 1d749dec-05cc-46f2-8bd3-7187d68e584d 61 fields · synced May 17, 2026
- EUDAMED dbcb0092-0f2b-4e7c-9357-22e5e09dc67c 61 fields · synced May 18, 2026
- EUDAMED f3003b43-f60b-479b-957e-e4090bc8e6d3 61 fields · synced May 18, 2026
- EUDAMED ea28fce3-12ba-44d9-8b94-22ab49aa451e 61 fields · synced May 18, 2026