Identity
- Trade Name
- Straight AO Mount Handle EUDAMED
- Device Name
- Straight AO Mount Handle EUDAMED
- Model / Reference
- INS-1107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391529585167 EUDAMED
- Basic UDI-DI
- B-05391529585167 EUDAMED539152958516777 EUDAMED
- Direct Marketing DI
- 05391529585167 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Straight AO Mount Handle by OrthoXel DAC — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05391529585167 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529585167 | Class I | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED f2aeae18-891d-4576-9620-9632a3d09230 61 fields · synced Jul 15, 2026
- EUDAMED 34e73537-a441-4cf1-b8e6-8431d760acf7 61 fields · synced May 17, 2026