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3.5mm Hex Short Driver Shaft
EUDAMEDClass I (EU MDR)
Ref INS-1108
by OrthoXel DAC
Identity
- Trade Name
- 3.5mm Hex Short Driver Shaft EUDAMED
- Device Name
- 3.5mm Hex Short Driver Shaft EUDAMED
- Model / Reference
- INS-1108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391529585174 EUDAMED
- Basic UDI-DI
- B-05391529585174 EUDAMED539152958517474 EUDAMED
- Direct Marketing DI
- 05391529585174 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
A medical device directory, with information on the 3.5mm Hex Short Driver Shaft. The device is classified as a Class I medical product and has undergone professional testing.
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-05391529585174 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529585174 | Class I | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 5d0776d8-771e-4efd-ba2d-6712b3b53614 61 fields · synced Jul 11, 2026
- EUDAMED 98916b37-dcbe-4409-89e0-17e7266d4c7e 61 fields · synced May 17, 2026