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Upper Arm Electronic Blood Pressure Monitor (U86E, TelliBP01)

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K241007Ref 06953825909536Model U80B

by Shenzhen Urion Technology Co., Ltd.

Identity

Trade Name
SDUNW FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Device Name
Upper Arm Electronic Blood Pressure Monitor EUDAMED
Model / Reference
U80B EUDAMEDFDA UDI
06953825909536 EUDAMED

Identifiers

Primary DI / UDI-DI
06953825909536 EUDAMEDFDA UDI
Basic UDI-DI
B-06953825909536 EUDAMED
510(k) Number
K241007 FDA 510(k)
FDA Product Code
DXN FDA 510(k)FDA UDI
EMDN Code
Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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
Northern Ireland 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

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Upper Arm Electronic Blood Pressure Monitor (U86E, TelliBP01) is an automated non-invasive device designed to measure systolic and diastolic blood pressure in adults. It employs oscillometric technology to inflate a cuff around the upper arm, detect arterial pulsations, and calculate blood pressure readings with digital display output. Suitable for home, clinical, and ambulatory use, it aligns with the nomenclature for automated blood pressure monitors (Device Type: DXN).

This device is supplied as a single-use or reusable system, depending on the cuff model, and requires no sterilisation. It is intended for use in environments where blood pressure monitoring is routine, such as hospitals, clinics, or patient homes. The monitor adheres to FDA 510K clearance under the Traditional pathway and MDD compliance, with a product code of DXN. Storage conditions include protection from extreme temperatures and direct sunlight, and the device must be calibrated periodically for accuracy.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Urion Technology Co., Ltd.

Sources (3)

  • FDA 510(k) K241007 24 fields · synced Oct 6, 2026
  • FDA UDI b2a206a0-7902-47d2-8ec5-9b34198ca9d1 32 fields · synced May 30, 2026
  • EUDAMED 99f15d74-5a40-406f-9c9a-e1c6a129bff3 61 fields · synced Jun 20, 2026