Electronic Sphygmomanometer
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Electronic Sphygmomanometer EUDAMEDCONTEC FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Electronic Sphygmomanometer EUDAMEDFDA UDI
- Model / Reference
- CONTEC08A EUDAMEDFDA UDICONTEC08C EUDAMEDFDA UDI
- Description
- Electronic Sphygmomanometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040100324 EUDAMEDFDA UDI06945040100331 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CONTEC08CAS EUDAMED69450401CONTEC08AAN EUDAMED
- Direct Marketing DI
- 06945040100331 EUDAMED06945040100324 EUDAMED
- FDA Product Code
- DXN FDA 510(k)FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist 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
- Croatia EUDAMEDNetherlands 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 Electronic Sphygmomanometer, a blood pressure measurement instrument designed to automatically inflate a cuff, detect Korotkoff sounds or oscillations, and display systolic and diastolic blood pressure readings. It falls under the category of automated blood pressure monitors, providing accurate measurements for clinical and home use in assessing cardiovascular health.
The device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, doctor’s offices, and home monitoring environments. It is not classified as sterile and requires proper calibration and maintenance per manufacturer guidelines. The device complies with FDA 510K and MDR regulatory standards, with a product code of DXN and K-number K110775. Storage and handling should follow standard medical device protocols to ensure accuracy and longevity.
Frequently asked questions
Is this device meant for single-use or can it be reused in a clinical setting?
This electronic sphygmomanometer is designed as a reusable medical instrument for clinical use in hospitals, doctor’s offices, or home monitoring. Since it is not sterile, it must be properly cleaned, calibrated, and maintained according to the manufacturer’s guidelines to ensure accuracy and hygiene between uses. Reusability is standard for non-sterile blood pressure measurement devices in regulated settings.
What regulatory pathways does this device follow, and how does that affect its use?
This device follows FDA 510(k) clearance (traditional pathway, K-number K110775, product code DXN) and MDR compliance, meaning it meets European regulatory standards as well. The clearance indicates it is deemed substantially equivalent to a predicate device, ensuring its safety and performance for clinical and home blood pressure monitoring. These pathways confirm its suitability for use in both healthcare facilities and patient self-monitoring environments.
How should I store this device to maintain its accuracy and functionality over time?
Storage should follow standard medical device protocols to preserve accuracy and longevity. Since it is a reusable, non-sterile instrument, avoid extreme temperatures, direct sunlight, and moisture. Store in a clean, dry environment away from sources of electromagnetic interference (e.g., other electronic devices) to prevent calibration drift. Always refer to the manufacturer’s instructions for specific storage recommendations, as improper handling can affect measurement reliability.
What types of environments is this device intended for, and does it work for both clinical and home use?
This electronic sphygmomanometer is explicitly designed for both clinical and home use, making it versatile for hospitals, doctor’s offices, and patient self-monitoring. Its automated cuff inflation and Korotkoff/oscillation detection ensure consistent readings in controlled settings like clinics, while its portability and ease of use also suit home monitoring. The FDA and MDR compliance further validate its suitability for these diverse environments.
Are there different models or sizes available for this device, or is it a one-size-fits-all design?
The provided data does not specify multiple models or sizes for this electronic sphygmomanometer, implying it is likely offered as a standardized design for general adult use. However, manufacturers often provide cuffs in various sizes (e.g., adult small, adult large) to accommodate different arm circumferences. Always verify with the manufacturer or distributor to confirm if additional cuff options are available for your specific patient population.
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 | K110775 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- FDA Applicant
- Contec Medical Systems Co.,Ltd
Sources (5)
- FDA 510(k) K110775 24 fields · synced Sep 18, 2026
- FDA UDI 550774ce-d0cc-4ffc-bc57-b902fed76d63 34 fields · synced May 30, 2026
- FDA UDI b269a557-ea02-47b4-8dec-26580d1e59d1 34 fields · synced May 30, 2026
- EUDAMED 3a8bd321-94e4-4e1f-bca2-66c387c351fa 61 fields · synced Jul 14, 2026
- EUDAMED 7c785bee-10c3-4282-94bd-f65936e9c6fd 61 fields · synced Jul 27, 2026