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Entropy EasyFit Sensor

by GE Healthcare Finland Oy

Ref M1174413

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

CE MDD 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) K103129↗

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/MDD EUDAMED NumberB-00840682102971 Basic UDI-DI 00840682102971UDI-DIDate15 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682102971 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK103129 Date19 Jul 2011IssuedStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Entropy
Generic Name
Analytical scalp electrode, single-use
Device Name
Entropy EasyFit Sensor
Model / Reference
M1174413, EasyFit sensor
Primary DI / UDI-DI
00840682102971
Basic UDI-DI
B-00840682102971
510(k) Number
FDA Product Code
GWQ
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
GMDN Term
Analytical scalp electrode, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
882.1400
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M1174413
GUDID
EasyFit sensor, M1174413
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

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

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Manufacturing Date: No