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Orthofix 42-2108

by Avalign Technologies Inc.

Part of a family of 9 devices: see the family page

Ref 42-2108

Orthofix 42-2108 is a Class I device made by Avalign Technologies Inc., registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 0190776TRIALXY) and listed in FDA GUDID since 17 Feb 2023 (UDI-DI 00190776149147), active as of 8 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776TRIALXY Basic UDI-DI 00190776149147UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776149147 UDI-DI Date17 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0190776TRIALXY registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 00190776149147 listed 17 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190776149147
  2. Registered EUDAMED 0190776TRIALXY

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Orthofix
Generic name
Surgical implant template, reusable
Device name
Bladder Sound
Model / reference
42-2108
Primary DI / UDI-DI
00190776149147
Basic UDI-DI
0190776TRIALXY
Direct marketing DI
00190776149147
FDA product code
HWT
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Surgical implant template, reusable
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Avalign Technologies Inc.

See all devices from Avalign Technologies Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)