Identity
- Trade Name
- EDX Bone Screw and Cap EUDAMED
- Device Name
- Bone Screws EUDAMED
- Model / Reference
- P010920 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817421022685 EUDAMED
- Basic UDI-DI
- 081742102XGUIDESCREWS2W EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
EDX Bone Screw and Cap by X-Nav Technologies, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081742102XGUIDESCREWS2W | Class IIa | Active |
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Manufacturer
- Manufacturer
- X-Nav Technologies, LLC
- EUDAMED SRN
- US-MF-000003234
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0ed93f6e-c03c-41b8-9750-bbe4147dcd6b 61 fields · synced Jun 18, 2026