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Goldtrace Fetal Spiral Electrode (FSE)

by Neoventa Medical AB

Ref CNS000004Model Fetal Spiral Electrode (FSE)

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243291↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number73401549FSEV8 Basic UDI-DI 07340154900027UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07340154900027 UDI-DI Date6 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK243291 Date17 Jan 2025IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Foetal scalp electrode, spiral
Model / Reference
Fetal Spiral Electrode (FSE), CNS000004
Primary DI / UDI-DI
07340154900027
Basic UDI-DI
73401549FSEV8
Unit of Use DI
07340154900003
510(k) Number
FDA Product Code
HGP
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Foetal scalp electrode, spiral
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
884.2675
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000001402

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Neoventa Medical AB

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No