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CARESCAPE VC150 Vital Signs Monitor

by Innokas Yhtymä Oy

Ref 2067980

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133810↗

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-00840682117722 Basic UDI-DI 00840682117722UDI-DIDate26 Nov 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number00840682117722 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK133810 Date30 Oct 2014IssuedStatusActive

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

3 recalls · FDA

    • Terminated Z-2604-2016 FDA Class II initiated 27 Jul 2016

    A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.

    • Terminated Z-0264-2016 FDA Class II initiated 22 Oct 2015

    Monitor may shut down unintentionally without restarting.

    • Terminated Z-1022-2015 FDA Class II initiated 3 Dec 2014

    If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Carescape
Generic Name
Multiple vital physiological parameter monitoring system, clinical
Device Name
CARESCAPE VC150 Vital Signs Monitor
Model / Reference
2067980 EUDAMED
VC150 GUDID
Primary DI / UDI-DI
00840682117722
Basic UDI-DI
B-00840682117722
510(k) Number
FDA Product Code
MWI
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN Term
Multiple vital physiological parameter monitoring system, clinical
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2300
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
2067980
GUDID
VC150
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000005374

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (19)

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