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Multi-parameter Patient Monitor NC10

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref NC10

by Shenzhen Comen Medical Instruments Co., LTD.

Identity

Trade Name
Multi-parameter Patient Monitor EUDAMED
Device Name
Multi-parameter Patient Monitor EUDAMED
Model / Reference
NC10 EUDAMED

Identifiers

Primary DI / UDI-DI
06945429020250 EUDAMED
Basic UDI-DI
B-06945429020250 EUDAMED
EMDN Code
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

The Multi-parameter Patient Monitor NC10 (Nomenclature Code: Z1203020201) is a Class IIb medical device designed for continuous, real-time monitoring of multiple physiological parameters in critical care settings. It measures vital signs such as ECG, blood pressure, pulse oximetry, and respiratory rate, enabling clinicians to assess patient stability and respond promptly to clinical changes.

This device is intended for single-use in clinical environments such as intensive care units (ICUs), operating rooms (ORs), and emergency wards. Supplied non-sterile and non-reusable, it is regulated under FDA 510K, MDD, and MDR compliance frameworks. The monitor is equipped with a Basic UDI (B-06945429020250) and is manufactured by Shenzhen Comen Medical Instruments Co., Ltd., with distribution handled by Lotus NL B.V.

Frequently asked questions

Is this monitor intended for repeated use in the same patient over multiple procedures, or is it designed for single-use only?

This monitor is explicitly designed for single-use only in clinical settings like ICUs, operating rooms, or emergency wards. The specifications confirm it is non-reusable (REUSABLE: 0) and supplied non-sterile, meaning it cannot be reprocessed or reused on the same or another patient.

What physiological parameters does this device monitor, and why is this important for critical care?

The Multi-parameter Patient Monitor NC10 continuously tracks ECG, blood pressure, pulse oximetry, and respiratory rate, enabling real-time assessment of patient stability. These parameters are critical in high-risk environments like ICUs or ORs, where sudden changes in vital signs can signal life-threatening conditions, allowing clinicians to intervene promptly.

How do I identify the correct model and regulatory compliance of this device when ordering?

The device model is NC10, with a Basic UDI (B-06945429020250) for traceability. It complies with FDA 510K, MDD, and MDR frameworks, and is distributed by Lotus NL B.V. in the EU. Always verify the UDI and nomenclature code (Z1203020201) to ensure compliance with local regulatory requirements.

Can this monitor be used in environments outside critical care, such as general wards or outpatient clinics?

While the monitor is intended for critical care settings (ICUs, ORs, emergency wards), its design for real-time monitoring of multiple vital signs could theoretically support high-acuity general wards or monitored outpatient areas—provided the clinical need aligns with its capabilities. However, its single-use, non-sterile nature may limit its suitability for lower-risk or non-invasive settings.

How should this device be stored to maintain its functionality and compliance with regulatory standards?

The monitor should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is non-sterile and single-use, storage conditions should prevent contamination or damage to sensors. Always check the expiration date (if applicable) and ensure the UDI label remains intact for traceability and compliance.

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. Sources consulted: Patient Monitors for ICU, OR & Emergency - Comen, Compact Multi-Parameter ICU Patient Monitor | COMEN K Pro Patient Monitor, PDF Multi-parameter Patient Monitor, Comen Medical Monitors | Patient Monitors

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

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

Manufacturer

EUDAMED SRN
CN-MF-000002236
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED 4ebc17ee-eff4-4dc2-8fcc-63be92e6ab18 61 fields · synced Oct 6, 2026
  • FDA 510(k) K211619 1 fields · synced May 18, 2026