Patient Monitor Q3
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Patient monitor EUDAMED
- Device Name
- Patient monitor EUDAMED
- Model / Reference
- Q3 EUDAMEDQ3, Q5, Q7, TRUSCOPE Ultra Q3, TRUSCOPE Ultra Q5, TRUSCOPE Ultra Q7, PG S30, PG S50, PG S70, LM7 EUDAMEDTRUSCOPE Ultra Q3 EUDAMEDG10, G12, G15, G10A, G12A, G15A EUDAMEDG10A EUDAMEDP12 EUDAMEDTruscope P22 EUDAMEDP1 EUDAMEDTruscope P1 EUDAMEDG12 EUDAMEDS12 EUDAMEDS12A EUDAMEDM1000 EUDAMEDTRUSCOPE touch mini EUDAMEDP15 EUDAMEDS10 EUDAMEDS10A EUDAMEDM10 EUDAMEDTRUSCOPE M10 EUDAMEDTruscope P15 EUDAMEDLM 1 EUDAMEDPG S50 EUDAMEDG15A EUDAMEDPG S70 EUDAMEDLM 7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932562300127 EUDAMED06932562300578 EUDAMED06932562301612 EUDAMED06932562300851 EUDAMED06932562300813 EUDAMED06932562301599 EUDAMED06932562300097 EUDAMED06932562300264 EUDAMED06932562300073 EUDAMED06932562300561 EUDAMED06932562300035 EUDAMED06932562300080 EUDAMED06932562300929 EUDAMED06932562300103 EUDAMED06932562300837 EUDAMED06932562301261 EUDAMED06932562301988 EUDAMED06932562301636 EUDAMED06932562301995 EUDAMED06932562301278 EUDAMED
- Basic UDI-DI
- 69325623100043X EUDAMED69325623100294F EUDAMED69325623100013R EUDAMED693256231001748 EUDAMED69325623100184A EUDAMED693256231000847 EUDAMED69325623100023T EUDAMED69325623100033V EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Patient Monitor Q3 is a Class IIb medical device classified under nomenclature code Z1203020201, designed for continuous monitoring of vital signs in clinical settings. It functions as an active monitoring system, providing real-time measurement of physiological parameters such as ECG, blood pressure, and other vital indicators to support patient assessment and care.
This device is non-sterile, non-reusable, and non-implantable, supplied as a single-use or reusable system depending on clinical protocol. It is authorized under FDA 510K and MDR regulations, with a Basic UDI of 69325623100043X. The monitor is intended for use in hospital wards, intensive care units, and emergency departments, adhering to standard medical device safety and performance criteria.
Frequently asked questions
Is this monitor designed for single-use or can it be reused in clinical settings?
The Patient Monitor Q3 is classified as non-reusable (REUSABLE: 0) according to its specifications. However, the device description notes it can be supplied as either single-use or reusable *depending on clinical protocol*, meaning its reuse would require adherence to specific reprocessing protocols not detailed in the data. Clinicians should follow established infection control and reprocessing guidelines if reuse is intended.
What vital signs does this device measure, and where is it typically used in a hospital?
The Patient Monitor Q3 measures physiological parameters such as ECG and blood pressure, along with other vital indicators, to support patient assessment. It is designed for use in hospital wards, intensive care units (ICUs), and emergency departments, where continuous monitoring of patients is critical.
How is the sterility of this device specified, and what does that mean for clinical use?
The device is explicitly marked as non-sterile (STERILE: 0), meaning it is not pre-sterilized for direct patient contact. Clinicians must follow standard disinfection protocols before use, particularly if the device is reused, to ensure patient safety and prevent infection.
What is the regulatory pathway for this device, and who is the authorized representative in Europe?
The Patient Monitor Q3 is authorized under both FDA 510K and MDR (Medical Device Regulation) pathways. In Europe, the authorized representative is Shanghai International Holding Corp. GmbH (Europe), based in Germany (SRN: DE-AR-000000001). This representative handles regulatory compliance and market surveillance for the device.
Does this device come with any accessories or consumables, and how is it supplied?
The provided data does not specify included accessories or consumables, but the device is supplied as a standalone system (non-implantable, non-sterile) for continuous monitoring. Clinicians should confirm with the manufacturer or distributor about required accessories, such as electrodes or cuffs, which may be sold separately.
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: Products_Guangdong Biolight Meditech Co., Ltd., Guangdong Biolight Meditech Co., Ltd., Products_Guangdong Biolight Meditech Co., Ltd. - gefair.com, Products_Guangdong Biolight Meditech Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162234 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K181919 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K112803 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K102040 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69325623100043X | Class IIb | Active |
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Manufacturer
- Manufacturer
- Guangdong Biolight Meditech Co., Ltd
- EUDAMED SRN
- CN-MF-000006333
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (21)
- EUDAMED 28f4308e-d1ad-458b-b480-2d47ed8d0e8d 61 fields · synced Sep 18, 2026
- EUDAMED be34f59d-21bd-421e-a5da-4faf7f324b9a 61 fields · synced May 16, 2026
- EUDAMED d3ffb864-208b-4f20-9eed-f72e72305d1c 61 fields · synced May 16, 2026
- EUDAMED 00783876-c0ab-422b-8237-8d963571111a 61 fields · synced May 17, 2026
- EUDAMED 0615015e-975d-47f2-bdfc-9060d715aa64 61 fields · synced May 17, 2026
- EUDAMED 4774a6d1-8764-4682-bdb5-bdcfaccd3b76 61 fields · synced May 17, 2026
- EUDAMED fc3024e5-41ad-46e2-bf75-b4b0b60a2858 61 fields · synced May 17, 2026
- EUDAMED e02e64bb-721c-476e-9617-8e4f3ca2ad4e 61 fields · synced May 17, 2026
- EUDAMED 039762f6-ceca-4db7-93f0-9ef8f1c17893 61 fields · synced May 17, 2026
- EUDAMED 8b22d6e5-d083-4529-b3d2-174fcfefccf9 61 fields · synced May 17, 2026
- EUDAMED 5d540306-dd79-4b68-acd8-32b73e537397 61 fields · synced May 17, 2026
- EUDAMED 75cf978a-2b2a-4760-b404-41f132e031b7 61 fields · synced May 17, 2026
- EUDAMED cad77947-c5ef-4b53-a9b7-49006e713c59 61 fields · synced May 18, 2026
- EUDAMED e0534a87-3b0e-4789-b8bd-7c4062685afc 61 fields · synced May 18, 2026
- EUDAMED a510adf7-4275-403f-8bfb-932a8881025e 61 fields · synced May 18, 2026
- EUDAMED 9c67b29c-8cfa-4e43-b73a-009a1c81e2cf 61 fields · synced May 18, 2026
- EUDAMED b6b0ed22-0e25-4362-8e67-72f3f879b5c9 61 fields · synced May 18, 2026
- EUDAMED 6e2060ca-30a1-4aff-9d5d-8121133071a9 61 fields · synced May 18, 2026
- EUDAMED 226dd8b7-d789-4b4c-81ac-383fe99643e7 61 fields · synced Jul 9, 2026
- EUDAMED e5c26374-8ce9-4aa7-b511-16ccba6ee369 61 fields · synced Jul 10, 2026
- FDA 510(k) K162234 1 fields · synced May 18, 2026