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BlueSensor NECG Electrodes N-50-K/25

by Ambu A/S

Ref N-50-K/25Model BlueSensor Wet gel

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5707480301005204587 Basic UDI-DI 05707480022120UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05707480022120 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Ambu® BlueSensor N EUDAMED
BlueSensor NECG Electrodes GUDID
Generic Name
Electrocardiographic electrode, single-use
Device Name
BlueSensor Wet gel
Model / Ref / Catalog
N-50-K/25, BlueSensor Wet gel
Primary DI / UDI-DI
05707480022120
Basic UDI-DI
5707480301005204587
Unit of Use DI
05707480023998
FDA Product Code
DRX
EMDN Code
C020501 ECG electrodes
GMDN Term
Electrocardiographic electrode, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2360
EU market of registration
Denmark
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Ambu A/S

See all devices from Ambu A/S →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • 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
  • Serial Number: No
  • Manufacturing Date: No