OptoMonitor 3
EUDAMEDFDA 510(k)Class IIb (EU MDR)
by Opsens Inc.
Identity
- Device Name
- OptoMonitor 3 EUDAMED
- Model / Reference
- F2300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540184023004 EUDAMED
- Basic UDI-DI
- B-07540184023004 EUDAMED
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: In-line arterial blood sampling set
The OptoMonitor 3 is a pressure transducer designed for measuring intravascular pressure, as classified under nomenclature code Z1203020301. It employs optical sensing technology to provide real-time hemodynamic monitoring, particularly suited for cardiovascular applications.
This device is non-sterile, non-reusable, and non-implantable, intended for single-use in clinical settings. It is not MRI-safe and is supplied as a catheter-tip transducer with a designated model number (F2300). Authorized under FDA 510(k) and MDD, it adheres to Class IIb regulatory standards and carries a Basic UDI (B-07540184023004). Storage and handling follow standard non-sterile medical device protocols.
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Frequently asked questions
What is the OptoMonitor 3 used for in clinical settings?
The OptoMonitor 3 is a catheter-tip pressure transducer designed specifically for measuring intravascular pressure in real-time. Its optical sensing technology makes it particularly suited for cardiovascular applications, such as monitoring hemodynamic parameters during procedures like cardiac catheterization or intra-operative assessments.
Is the OptoMonitor 3 reusable or single-use, and how should it be handled?
The OptoMonitor 3 is intended for single-use only and is non-reusable. Since it is non-sterile, it must be handled according to standard non-sterile medical device protocols. This means it should not be reused between patients and should be disposed of after one use, following facility-specific guidelines for non-sterile devices.
What model number and regulatory identifiers should I reference when ordering or documenting this device?
The OptoMonitor 3 is supplied under the model number F2300. For regulatory documentation, you may reference its Basic UDI (B-07540184023004) or the FDA 510(k) number (K193620). It is also authorized under the MDD (Medical Device Directive) and classified as Class IIb under EU regulatory standards.
Can the OptoMonitor 3 be used in an MRI environment, and what are its storage requirements?
The OptoMonitor 3 is not MRI-safe, so it should not be used in magnetic resonance imaging environments. For storage, it follows standard protocols for non-sterile medical devices—keep it in a dry, clean environment, protected from physical damage, and away from direct sunlight or extreme temperatures, as specified by the manufacturer.
Who is the manufacturer and authorized representative for the OptoMonitor 3, and how can I contact them?
The manufacturer of the OptoMonitor 3 is Opsens Inc., based in Quebec, Canada. The authorized representative in the EU is MDSS GmbH. For inquiries, you may contact Marc Chaunet at Opsens Inc. via the provided address (750 Blvd. Du Parc Technologique, G1P 4S3, Quebec, Canada).
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
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241418 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K251367 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202943 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K193620 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-07540184023004 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Opsens Inc.
- EUDAMED SRN
- CA-MF-000018361
- FDA Applicant
- Opsens, Inc.
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2e34ba01-194d-4794-8f81-defbd5ed64c1 85 fields · synced Sep 18, 2026
- FDA 510(k) K241418 1 fields · synced May 18, 2026