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EDX Bone Screw and Cap

EUDAMED

Class IIa (EU MDR)

Ref P010923Ref P010922Ref P010924Ref P010925Ref P010921

by X-Nav Technologies, LLC

Identity

Trade Name
EDX Bone Screw and Cap EUDAMED
Device Name
Bone Screws EUDAMED
Model / Reference
P010923 EUDAMED
P010922 EUDAMED
P010924 EUDAMED
P010925 EUDAMED
P010921 EUDAMED

Identifiers

Primary DI / UDI-DI
00817421022715 EUDAMED
00817421022708 EUDAMED
00817421022722 EUDAMED
00817421022739 EUDAMED
00817421022692 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

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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 (5)

  • EUDAMED bc061852-4648-46d9-ab06-3885efcc9da5 61 fields · synced Sep 18, 2026
  • EUDAMED 7bc01371-6901-4425-9cdf-5e4732e4601d 61 fields · synced May 16, 2026
  • EUDAMED 85c45d4f-8f59-443c-b2e2-d0cc326b3326 61 fields · synced May 17, 2026
  • EUDAMED afa9fdca-505b-45f7-b7bf-9dd5c322445a 61 fields · synced May 17, 2026
  • EUDAMED 1b2c4fed-155e-4c84-89ce-216712ebbf3c 61 fields · synced May 18, 2026