Ds-11
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- DS-11 EUDAMED
- Device Name
- DS-A10 EUDAMED
- Model / Reference
- Non-Invasive Digital Blood Pressure Monitor EUDAMEDDS-B10-22D EUDAMEDDS-B10-15D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04931140012119 EUDAMED04931140012034 EUDAMED
- Basic UDI-DI
- 4931140DS-A10EV9F EUDAMED
- Direct Marketing DI
- 04931140012119 EUDAMED04931140012034 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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 DS-11 is a Non-Invasive Digital Blood Pressure Monitor, designed to measure systolic and diastolic blood pressure and pulse rate in adults. Classified under nomenclature code Z1203020501, it operates as an active medical device with a built-in electronic system for accurate readings. Suitable for clinical and home use, it adheres to Class IIa risk classification standards.
This device is non-sterile, non-reusable, and intended for single-use applications. It complies with FDA 510(k) and MDR regulatory requirements and is supplied with a reference code DS-B10-22D. The monitor is non-implantable and does not contain latex, animal tissues, or endocrine disruptors. Storage and handling follow standard medical device protocols, with no specific MRI safety considerations noted.
Frequently asked questions
What types of measurements does the DS-11 blood pressure monitor provide, and is it suitable for both clinical and home use?
The DS-11 measures systolic and diastolic blood pressure as well as pulse rate in adults. It is explicitly designed for both clinical and home use, making it versatile for healthcare settings and patient self-monitoring at home.
Is the DS-11 device reusable, and if not, how should it be handled after use?
The DS-11 is non-reusable and intended for single-use only. Since it is non-sterile, it should be disposed of after one use following standard medical device waste protocols to ensure proper hygiene and infection control.
Does the DS-11 contain any materials that could pose allergies or safety concerns, such as latex or endocrine disruptors?
No, the DS-11 does not contain latex, animal tissues, or endocrine disruptors, making it safer for users with sensitivities to these substances. This is explicitly stated in the device’s specifications.
What regulatory pathways has the DS-11 followed, and what does this mean for its compliance?
The DS-11 has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). This means it meets U.S. and European standards for safety, performance, and manufacturing quality, ensuring reliability for clinical and home use.
How should the DS-11 be stored, and are there any special handling instructions beyond standard medical device protocols?
The DS-11 follows standard medical device storage and handling protocols, with no additional MRI safety considerations or special instructions noted. This means it should be kept in a clean, dry environment away from extreme temperatures or direct sunlight, as with most electronic medical devices.
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: Blood Pressure Monitor for Upper Arm | NIHON SEIMITSU SOKKI CO., LTD., NIHON SEIMITSU SOKKI CO.,LTD.Japan | Blood pressure,Thermometer,Pulse ..., NIHON SEIMITSU SOKKI NISSEI DS-11 Instructoin Manual, NIHON SEIMITSU SOKKI NISSEI DS-11 Instructoin Manual
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112620 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K112690 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K112691 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4931140DS-A10EV9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nihon Seimitsu Sokki Co., Ltd.
- EUDAMED SRN
- JP-MF-000018344
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 28619e49-995b-403f-8e63-bbd87498947f 61 fields · synced Sep 18, 2026
- EUDAMED 3c6179d4-072a-42c4-9d4d-b943b49cd6bc 61 fields · synced May 18, 2026
- FDA 510(k) K112620 1 fields · synced May 18, 2026