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BRUSIO 2.5mm Flex Straight Plate, 14 Hole

by Bonebridge AG EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref B-172014Model BRUSIO Trauma Toolbox Plate

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764018746BRUSIOMP Basic UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640187463248 UDI-DIDate15 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Device Name
Brusio
Model / Reference
BRUSIO Trauma Toolbox Plate, B-172014
Primary DI / UDI-DI
07640187463248
Basic UDI-DI
764018746BRUSIOMP
Direct Marketing DI
07640187463248
510(k) Number
FDA Product Code
HRS
EMDN Code
P09120599 Bone fixation plates - other
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000013933
Authorised representative
Axxos GmbH DE-AR-000005590

Other devices from Bonebridge AG

See all devices from Bonebridge AG →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No