← Back to catalogue

N-CAiO

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref N-CAiO-00

by GE Healthcare Finland Oy

Identity

Trade Name
NA FDA UDI
Generic Name
Patient monitoring system module, multiple-gas FDA UDI
Device Name
N-CAiO EUDAMED
E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE, N-CAiO EUDAMED
Model / Reference
N-CAiO-00 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00840682104074 EUDAMEDFDA UDI
Basic UDI-DI
B-00840682104074 EUDAMED
08406821BUG004677L EUDAMED
Direct Marketing DI
00840682104074 EUDAMED
510(k) Number
K133576 FDA UDI
FDA Product Code
FLL FDA UDI
DSK FDA UDI
CBS FDA UDI
NHO FDA UDI
CBR FDA UDI
CBQ FDA UDI
DSB FDA UDI
BZQ FDA UDI
DXN FDA UDI
NHQ FDA UDI
CCK FDA UDI
DQA FDA UDI
CCL FDA UDI
GWQ FDA UDI
DRT FDA UDI
MHX FDA UDI
NHP FDA UDI
EMDN Code
Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Patient monitoring system module, multiple-gas FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
870.1110 FDA UDI
868.1620 FDA UDI
868.1500 FDA UDI
868.1700 FDA UDI
870.2770 FDA UDI
868.2375 FDA UDI
870.1130 FDA UDI
868.1400 FDA UDI
870.2700 FDA UDI
868.1720 FDA UDI
882.1400 FDA UDI
870.2300 FDA UDI
870.1025 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

Yes

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

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (3)

  • EUDAMED d83ea79a-b917-4f19-95d3-3300165fcd76 61 fields · synced Oct 6, 2026
  • EUDAMED c31b3272-1e0d-4838-883b-767a4ea220a6 61 fields · synced May 18, 2026
  • FDA UDI 17aa91a9-c716-4a3d-b723-073c47720aae 35 fields · synced May 30, 2026