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Carescape Rad

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref CARESCAPE RADModel MBRA001

by GE Healthcare Finland Oy

Identity

Trade Name
CARESCAPE RAD EUDAMEDFDA UDI
Generic Name
Physiologic monitoring system alarm FDA UDI
Device Name
CARESCAPE RAD EUDAMEDFDA UDI
Model / Reference
MBRA001 EUDAMEDFDA UDI
CARESCAPE RAD EUDAMED
Description
CARESCAPE RAD FDA UDI

Identifiers

Catalog Number
CARESCAPE-RAD FDA UDI
Primary DI / UDI-DI
00840682123433 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00439HT EUDAMED
B-00840682123433 EUDAMED
Direct Marketing DI
00840682123433 EUDAMED
510(k) Number
K213363 FDA UDI
FDA Product Code
CBS FDA UDI
DSI FDA UDI
ORT FDA UDI
DXG FDA UDI
BZQ FDA UDI
GWJ FDA UDI
CCK FDA UDI
DQK FDA UDI
CBR FDA UDI
DPZ FDA UDI
BZK FDA UDI
NHQ FDA UDI
KOI FDA UDI
CCL FDA UDI
OMC FDA UDI
DQA FDA UDI
DSK FDA UDI
FLL FDA UDI
NHO FDA UDI
MLD FDA UDI
MHX FDA UDI
DPS FDA UDI
BZL FDA UDI
DSJ FDA UDI
NHP FDA UDI
DXN FDA UDI
OLT FDA UDI
CBQ FDA UDI
KRB FDA UDI
CAP FDA UDI
OLW FDA UDI
GWQ FDA UDI
DRT FDA UDI
EMDN Code
Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Physiologic monitoring system alarm FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.1620 FDA UDI
870.1025 FDA UDI
882.1400 FDA UDI
870.1435 FDA UDI
868.2375 FDA UDI
882.1900 FDA UDI
868.1400 FDA UDI
870.1425 FDA UDI
868.1700 FDA UDI
870.2710 FDA UDI
868.1850 FDA UDI
868.1500 FDA UDI
868.2775 FDA UDI
868.1720 FDA UDI
870.2700 FDA UDI
870.1110 FDA UDI
880.2910 FDA UDI
870.2340 FDA UDI
868.1730 FDA UDI
870.1100 FDA UDI
870.1130 FDA UDI
870.1915 FDA UDI
868.2600 FDA UDI
870.2300 FDA UDI
Market of Registration
Finland EUDAMED
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

No

EUDAMED

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 Rad by GE Healthcare Finland Oy — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

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

Sources (3)

  • EUDAMED 45218f5f-0a52-48f1-958e-6771f3b7e92a 61 fields · synced Oct 7, 2026
  • EUDAMED cf54cdc2-9c50-443c-a437-359da9aaa95c 61 fields · synced May 19, 2026
  • FDA UDI a0f88ef4-bc0a-4e80-b9aa-811d1e47078c 37 fields · synced May 30, 2026