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TruSignal SpO2 MM 3.0M

by GE Healthcare Finland Oy

Ref 5976977Model 5956015

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278949752 UDI-DI Date4 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08406821BUG006197K Basic UDI-DI 00195278949752UDI-DIDate27 Nov 2025RegisteredStatusActive

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 2 Nov 2026.

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  • Withdrawn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
Patient monitoring system module, pulse oximetry
Device Name
TruSignal SpO2 MM 1.8M
Model / Ref / Catalog
5956015, 5976977, 1
Primary DI / UDI-DI
00195278949752
Basic UDI-DI
08406821BUG006197K
Direct Marketing DI
00195278949752
510(k) Number
FDA Product Code
BZQ, CCK, DPS, DPZ, DQA, QEM, DQK, MUD, DRT, MHX, DSI, DSJ, FLL, DSK, MLD, DXN
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Patient monitoring system module, pulse oximetry
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.2375, 868.1400, 870.2340, 870.2710, 870.2700, 870.1425, 870.2300, 870.1025, 870.1100, 880.2910, 870.1110, 870.1130
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
5956015
5976977
GUDID
1
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No