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Ambu® WhiteSensor 40554

by Ambu A/S

Ref 40554Model WhiteSensor Solid gel

Ambu® WhiteSensor 40554 is a device classified as Class I in the EU and Class II in the US made by Ambu A/S, registered in EUDAMED on 22 Jun 2026 (Basic UDI-DI 570748030100520257Z) and listed in FDA GUDID since 7 Aug 2026 (UDI-DI 05060038511034), active as of 24 Oct 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060038511034 UDI-DI Date7 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number570748030100520257Z Basic UDI-DI 05060038511034UDI-DIDate22 Jun 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 570748030100520257Z registered 22 Jun 2026 Active
  • FDA GUDID UDI-DI 05060038511034 listed 7 Aug 2026 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Registered EUDAMED 570748030100520257Z
  2. Listed FDA GUDID 05060038511034

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  • Withdrawn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

Generic name
Neonatal electrocardiographic electrode
Device name
WhiteSensor Solid gel
Model / Ref / Catalog
40554, WhiteSensor Solid gel
Primary DI / UDI-DI
05060038511034
Basic UDI-DI
570748030100520257Z
Unit of use DI
05707480129249
FDA product code
DRX
EMDN code
C020501 ECG electrodes
GMDN term
Neonatal electrocardiographic electrode
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2360
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
Size
Width — 22 Millimeter
Length — 22 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Similar devices in this category

Other devices filed under ECG ELECTRODES.

Other devices from Ambu A/S

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)