Multi-parameter Patient Monitor NC10
EUDAMEDFDA 510(k)Class IIb (EU MDR)
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
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
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
CE/MDR
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06945429020250 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K211619 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K250854 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06945429020250 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- 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