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Carescape Canvas Smart Display

EUDAMEDFDA 510(k)FDA UDI

Class IIb (EU MDR)

Ref 5962265510(k) K223531Ref 5897061

by GE Healthcare Finland Oy

Identity

Trade Name
Carescape Canvas Smart Display EUDAMED
CARESCAPE Canvas D19 FDA UDI
Generic Name
Image display unit, colour FDA UDI
Device Name
Carescape Canvas Smart Display EUDAMED
CARESCAPE Canvas D19 EUDAMEDFDA UDI
Model / Reference
5962265 EUDAMED
5897061 EUDAMEDFDA UDI
Description
CARESCAPE Canvas D19 FDA UDI

Identifiers

Catalog Number
5897061 FDA UDI
Primary DI / UDI-DI
00195278884817 EUDAMED
00195278523365 EUDAMEDFDA UDI
Basic UDI-DI
08406821BUG0061479 EUDAMED
8406821BUG00290HH EUDAMED
510(k) Number
K223531 FDA 510(k)FDA UDI
FDA Product Code
MHX FDA 510(k)FDA UDI
CBS FDA UDI
BZL FDA UDI
MLD FDA UDI
DQK FDA UDI
NHP FDA UDI
DPZ FDA UDI
KOI FDA UDI
CAP FDA UDI
OLW FDA UDI
DSI FDA UDI
DXN FDA UDI
BZQ FDA UDI
CCL FDA UDI
BZK FDA UDI
DRT FDA UDI
DQA FDA UDI
FLL FDA UDI
GWQ FDA UDI
MUD FDA UDI
CBR FDA UDI
NHQ FDA UDI
DSK FDA UDI
GWJ FDA UDI
DXG FDA UDI
CBQ FDA UDI
ORT FDA UDI
OMC FDA UDI
DSJ FDA UDI
OLT FDA UDI
KRB FDA UDI
NHO FDA UDI
QEM FDA UDI
CCK FDA UDI
EMDN Code
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Image display unit, colour FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)FDA UDI
868.1620 FDA UDI
868.1730 FDA UDI
870.1425 FDA UDI
868.1500 FDA UDI
870.2710 FDA UDI
868.2775 FDA UDI
868.2600 FDA UDI
882.1400 FDA UDI
870.1130 FDA UDI
868.2375 FDA UDI
868.1720 FDA UDI
868.1850 FDA UDI
870.2300 FDA UDI
870.2700 FDA UDI
880.2910 FDA UDI
868.1700 FDA UDI
870.1110 FDA UDI
882.1900 FDA UDI
870.1435 FDA UDI
870.1100 FDA UDI
870.1915 FDA UDI
868.1400 FDA UDI
Market of Registration
Finland EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMEDEUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Carescape Canvas Smart Display by GE Healthcare Finland Oy — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
GE Healthcare Finland Oy
EUDAMED SRN
FI-MF-000001176

Sources (4)

  • EUDAMED 38d29d25-6d53-4b17-9783-0e56dd74d0d4 61 fields · synced Oct 6, 2026
  • FDA 510(k) K223531 24 fields · synced May 18, 2026
  • FDA UDI 4f2fabfa-89e1-46be-9dca-a307789e2d44 36 fields · synced May 30, 2026
  • EUDAMED 1d798e07-313d-4477-b35e-44e3b21cf5d0 61 fields · synced Jul 20, 2026