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Self-breaking Screw Ø2 Lg 11 mm
EUDAMEDClass IIb (EU MDR)
Ref 14.52.11Model SBS
by Ortho Cape
Identity
- Trade Name
- Self-breaking Screw Ø2 Lg 11 mm EUDAMED
- Device Name
- Self-breaking Screw Ø2 Lg 11 mm EUDAMED
- Model / Reference
- SBS EUDAMED14.52.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760347452692 EUDAMED
- Basic UDI-DI
- B-03760347452692 EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Self-breaking Screw Ø2 Lg 11 mm by Ortho Cape — Class IIb — 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-03760347452692 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ortho Cape
- EUDAMED SRN
- FR-MF-000028862
Sources (1)
- EUDAMED e6d4ee59-56eb-4374-b4fd-58dbe4124cee 61 fields · synced Jul 13, 2026