Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Ambulatory Blood Pressure Monitor EUDAMEDCONTEC FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- Ambulatory Blood Pressure Monitor EUDAMEDAutomatic Blood Pressure Monitor FDA UDI
- Model / Reference
- ABPM50 EUDAMEDFDA UDI
- Description
- Automatic Blood Pressure Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040100348 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401ABPM50D4 EUDAMED
- Direct Marketing DI
- 06945040100348 EUDAMED
- 510(k) Number
- FDA Product Code
- DXN FDA 510(k)FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
This device is an ambulatory blood pressure monitor and electronic sphygmomanometer, designed to measure blood pressure continuously over extended periods outside of a clinical setting. It falls under the classification of a non-invasive blood pressure monitoring device, enabling automated recordings for ambulatory use while maintaining accuracy and reliability for diagnostic purposes.
The device is supplied as a reusable electronic system, intended for use in both clinical and home settings. It complies with FDA 510K and MDR regulatory standards, with a product code of DXN under the Cardiovascular advisory committee. No third-party review was required, and the device is classified as substantially equivalent under traditional clearance pathways.
Frequently asked questions
Is this device meant for one-time use or can it be reused in clinical or home settings?
This device is designed as a reusable electronic system, meaning it is intended for repeated use in both clinical and home environments. Since it is not classified as single-use, proper cleaning and maintenance procedures must be followed to ensure accuracy and hygiene between uses.
What regulatory pathways does this device follow, and how does that affect its use?
The device follows FDA 510K and MDR (Medical Device Regulation) pathways, with a traditional clearance under the Cardiovascular advisory committee (product code DXN). This means it was determined to be substantially equivalent to a predicate device, allowing for its commercialization without third-party review. Clinicians and buyers can rely on its compliance with these standards for diagnostic blood pressure monitoring.
How does the device differ from traditional sphygmomanometers in terms of functionality?
Unlike traditional sphygmomanometers, which require manual readings, this ambulatory blood pressure monitor provides continuous, automated recordings over extended periods outside of a clinical setting. This makes it ideal for tracking blood pressure trends in real-world conditions, such as during daily activities or sleep, rather than just single-point measurements.
What should buyers consider regarding storage and maintenance of this device?
Since this is a reusable electronic system, buyers should follow manufacturer guidelines for cleaning, calibration, and storage to maintain accuracy and longevity. Proper storage conditions (e.g., avoiding extreme temperatures or humidity) are critical, as the device relies on precise electronic components for reliable blood pressure measurements. Always refer to the included instructions for specific care protocols.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110156 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical System Co., Ltd.
Sources (3)
- FDA 510(k) K110156 24 fields · synced Oct 6, 2026
- FDA UDI df272fef-7eaf-4f55-8dcd-725df9326a35 34 fields · synced May 29, 2026
- EUDAMED 4e0dcf8f-329a-4c58-9b5d-bbe1baed452e 61 fields · synced Jul 21, 2026