Arm-type Fully Automatic Digital Blood Pressure Monitor DBP-1369
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Arm-type Fully Automatic Digital Blood Pressure Monitor EUDAMEDArm type Fully Automatic Digital Blood Pressure Monitor EUDAMED
- Device Name
- Blood Pressure Monitor EUDAMEDArm-type Fully Automatic Digital Blood Pressure Monitor EUDAMED
- Model / Reference
- DBP-1369 EUDAMEDDBP-1359 EUDAMEDDBP-6279B-P EUDAMEDDBP-6179-P EUDAMEDDBP-6279B EUDAMEDDBP-6191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392216249 EUDAMED26970392216212 EUDAMED06942284608920 EUDAMED06942284608722 EUDAMED06970392213507 EUDAMED06970392216799 EUDAMED
- Basic UDI-DI
- 6970392211BP0001Y5 EUDAMED6970392211BP0010Y6 EUDAMED6970392211BP0009YM EUDAMED6970392211BP0005YD EUDAMED6970392211BP0004YB EUDAMED
- Direct Marketing DI
- 06942284608920 EUDAMED06942284608722 EUDAMED06970392216799 EUDAMED
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMEDGermany 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 Arm-type Fully Automatic Digital Blood Pressure Monitor is a medical device designed to measure blood pressure levels. It functions as an automated diagnostic tool to provide digital readings for clinical or personal health monitoring.
This device is manufactured by Joytech Healthcare Co., Ltd. and is classified as a Class IIa medical device. It is not sterile, not intended for implantation, and is not a reprocessed device.
Frequently asked questions
Is the Joytech DBP-1369 a reusable device?
The device specifications indicate that it is not classified as a reusable device, meaning it is intended for specific operational use as defined by the manufacturer.
Does this blood pressure monitor contain latex?
No, the device specifications confirm that the monitor is latex-free, making it suitable for users with latex sensitivities.
What regulatory standards does this monitor meet?
The device is authorized under FDA 510K and MDR regulations, ensuring it meets the necessary requirements for its classification as a Class IIa medical device.
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: [PDF] The Arm-type Fully Automatic Digital Blood Pressure Monitors ..., Blood Pressure Monitor - Joytech Healthcare, FCC ID 2AQVU0055 Arm-type Fully Automatic Digital Blood Pressure Monitor by JOYTECH HEALTHCARE CO., LTD., JOYTECH HEALTHCARE DBP-62D0L Arm Type Fully Automatic Digital Blood Pressure Monitor Owner’s Manual - Manuals+
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
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 | K230566 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212115 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K200649 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K241431 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181104 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250548 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252685 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252501 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231303 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211BP0001Y5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (7)
- EUDAMED d50114af-dee9-42bc-b06d-a89a227099d1 61 fields · synced Oct 6, 2026
- EUDAMED 1b02a5ca-88c8-43ee-b488-bec2fe66c78a 61 fields · synced May 16, 2026
- EUDAMED bc0b592e-16ff-4f6c-ba7f-fb4ddafe9206 61 fields · synced May 17, 2026
- EUDAMED 8c8c176d-37a5-41fd-9189-f0fe72f16061 61 fields · synced May 17, 2026
- EUDAMED a4cf2050-f19f-476f-b97f-95f9d8907f2c 61 fields · synced May 18, 2026
- EUDAMED b42adf68-bd6b-4e68-8621-7aec30ac824b 61 fields · synced May 19, 2026
- FDA 510(k) K230566 1 fields · synced Jun 9, 2026