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Carescape B450

by GE Healthcare Finland Oy

Ref 5805686Model MBA323

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

CE MDR CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191249↗

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
United StatesGUDID listing GUDID Number00840682146135 UDI-DI Date13 May 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number8406821BUG00123GV Basic UDI-DI 00840682146135UDI-DIDate9 Mar 2022RegisteredStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00123GV Basic UDI-DI 00840682146135UDI-DIDate9 Mar 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK191249 Date24 Jan 2020IssuedStatusActive

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-0453-2026 FDA Class II initiated 26 Sep 2025

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Carescape EUDAMED
Carescape B450 GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
MBA323, 5805686
Primary DI / UDI-DI
00840682146135
Basic UDI-DI
8406821BUG00123GV, B-00840682146135
510(k) Number
FDA Product Code
DSI, DQK, NHO, MUD, DPS, DXN, CCL, DSK, CBS, MHX, KOI, NHP, CBR, DQA, DPZ, KRB, DXG, OLT, GWJ, QEM, BZL, NHQ, CAP, OLW, BZQ, MLD, FLL, CBQ, CCK, ORT, OMC, DSJ, DRT, BZK, GWQ
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025, 870.1425, 868.1500, 870.2700, 870.2340, 870.1130, 868.1720, 870.1110, 868.1620, 868.2775, 868.1700, 870.2710, 870.1915, 870.1435, 882.1400, 882.1900, 868.1730, 868.2600, 868.2375, 880.2910, 868.1400, 870.1100, 870.2300, 868.1850
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (21)

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