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Bladder Sound

by Avalign Technologies Inc.

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

Ref 03.012.101

Bladder Sound (03.012.101) 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 5 Oct 2021 (UDI-DI 00190776160340), 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 00190776160340UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776160340 UDI-DI Date5 Oct 2021ListedStatusListed 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 00190776160340 listed 5 Oct 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00190776160340
  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  • Withdrawn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
DePuy
Generic name
Abdominal/ENT/orthopaedic surgical probe, reusable
Model / reference
03.012.101
Primary DI / UDI-DI
00190776160340
Basic UDI-DI
0190776TRIALXY
Direct marketing DI
00190776160340
FDA product code
FGM
EMDN code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class I
Regulation number
876.4730
EU registration type
Standard device
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000008511
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Hand-held surgical retractor, reusable

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER.

Other devices from Avalign Technologies Inc.

See all devices from Avalign Technologies Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)