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X-Guide Bone Screws
EUDAMEDClass IIa (EU MDR)
Ref P008836Ref P008842Ref P008835Ref P008840Ref P008841Ref P008837Ref P007839Ref P008843
Identity
- Trade Name
- X-Guide Bone Screws EUDAMEDX-Guide EUDAMED
- Device Name
- Bone Screws EUDAMEDX-Guide Surgical Navigation System EUDAMED
- Model / Reference
- P008836 EUDAMEDP008842 EUDAMEDP008835 EUDAMEDP008840 EUDAMEDP008841 EUDAMEDP008837 EUDAMEDP007839 EUDAMEDP008843 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817421022968 EUDAMED00817421023019 EUDAMED00817421022951 EUDAMED00817421022999 EUDAMED00817421023002 EUDAMED00817421022975 EUDAMED00817421020032 EUDAMED00817421023026 EUDAMED
- Basic UDI-DI
- 081742102XGUIDESCREWS2W EUDAMEDB-00817421020032 EUDAMED
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMEDZ12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
X-Guide Bone Screws by X-Nav Technologies, LLC — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081742102XGUIDESCREWS2W | Class IIa | Active |
| 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 (8)
- EUDAMED 17fa9005-4214-4889-bc39-b5a2a482eebd 61 fields · synced Aug 2, 2026
- EUDAMED 11f3c1a0-4826-4ac6-94a7-6b24ac9fa82c 61 fields · synced May 17, 2026
- EUDAMED ecf56fe3-18e8-4794-905a-12e2fce0d45d 61 fields · synced May 17, 2026
- EUDAMED af0367a3-6abf-45bf-b7b2-8bc5b4c81137 61 fields · synced May 17, 2026
- EUDAMED 098b5083-a6e2-4053-ba23-d5d2086c7764 61 fields · synced May 18, 2026
- EUDAMED de15b518-fd91-4a59-87e9-e3f6a91032fd 61 fields · synced May 18, 2026
- EUDAMED 34c52bf3-a559-49f7-86fb-df1c56bb2343 61 fields · synced May 18, 2026
- EUDAMED 0a1a0d2b-17c3-420a-8bf5-2630b8d36da5 61 fields · synced May 19, 2026