Edan Patient Monitor CX10

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref CX10

by Edan Instruments, Inc.

Identity

Trade Name: Patient Monitor EUDAMEDFDA UDI
Generic Name: General-purpose multi-parameter bedside monitor FDA UDI
Device Name: Patient Monitor EUDAMED
Model / Reference: CX10 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06944413838406 EUDAMEDFDA UDI
Basic UDI-DI: 69444138CXS4F EUDAMED
510(k) Number: K250179 FDA UDI
FDA Product Code: CCL FDA UDI
MHX FDA UDI
BZQ FDA UDI
CCK FDA UDI
DPS FDA UDI
DQA FDA UDI
DRT FDA UDI
DSI FDA UDI
DSK FDA UDI
MLD FDA UDI
DXN FDA UDI
FLL FDA UDI
EMDN Code: Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
GMDN Term: General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 868.1720 FDA UDI
870.1025 FDA UDI
868.2375 FDA UDI
868.1400 FDA UDI
870.2340 FDA UDI
870.2700 FDA UDI
870.2300 FDA UDI
870.1110 FDA UDI
870.1130 FDA UDI
880.2910 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

The Edan Patient Monitor CX10 is a medical device designed to perform essential patient monitoring functions. It is classified as a Class IIb device with a measuring function, providing clinical data for patient assessment.

This device is manufactured by Edan Instruments, Inc. and is compliant with MDR and FDA 510K regulatory requirements. It is not sterile, not implantable, and does not contain animal or human tissues, latex, or endocrine disruptors.

Frequently asked questions

Is the Edan Patient Monitor CX10 sterile?

No, the device is not sterile. It is designed for clinical environments where standard cleaning and maintenance protocols are followed according to the manufacturer's specifications.

What is the regulatory classification of this monitor?

The Edan Patient Monitor CX10 is classified as a Class IIb device, which indicates it is a medical device with a measuring function subject to specific regulatory oversight under MDR and FDA 510K standards.

Does the CX10 monitor contain any hazardous materials?

No, the device does not contain latex, animal tissues, human tissues, or endocrine-disrupting substances, ensuring it meets safety standards for patient contact.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K110922	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K120173	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K160981	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K152552	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K113653	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K192514	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K202336	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K113623	Class IIb	Active
EUDAMED	European Union	CE/MDR	69444138CXS4F	Class IIb	Active

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Manufacturer

Manufacturer: Edan Instruments, Inc.
EUDAMED SRN: CN-MF-000009957
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

EUDAMED 7e78aedc-334e-4ec7-9ea1-f1cf6ae18b9b 61 fields · synced Sep 18, 2026
FDA UDI 75695f56-a490-4517-8d76-4391ca638a9a 33 fields · synced May 30, 2026
FDA 510(k) K110922 1 fields · synced May 18, 2026