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CONTEC Baby Sound C

by Contec Medical Systems Co., Ltd.

Ref Baby Sound C

CONTEC Baby Sound C is a device classified as Class IIa in the EU and Class II in the US made by Contec Medical Systems Co., Ltd., registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI B-06945040104612), cleared under FDA 510(k) K082480 on 25 Feb 2009 and listed in FDA GUDID since 23 May 2018 (UDI-DI 06945040104612), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K082480

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06945040104612 Basic UDI-DI 06945040104612UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945040104612 UDI-DI Date23 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082480 Date25 Feb 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06945040104612 registered 8 Jul 2026 Active
  • FDA 510(k) K082480 decided 25 Feb 2009 Active
  • FDA GUDID UDI-DI 06945040104612 listed 23 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082480
  2. Listed FDA GUDID 06945040104612
  3. Registered EUDAMED B-06945040104612

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pocket Fetal Doppler EUDAMED
Contec GUDID
Generic name
Foetal Doppler system probe
Model / reference
Baby Sound C
Primary DI / UDI-DI
06945040104612
Basic UDI-DI
B-06945040104612
510(k) Number
FDA product code
KNG
EMDN code
Z12080103 Foetal heartbeat detectors
GMDN term
Foetal Doppler system probe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
884.2660
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Foetal Doppler systemFoetal Doppler system probe

Cleared under the same submission (K082480)

and 8 more cleared under K082480

Similar devices in this category

Other devices filed under FOETAL HEARTBEAT DETECTORS.

Other devices from Contec Medical Systems Co., Ltd.

See all devices from Contec Medical Systems Co., Ltd. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)