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Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K181154Ref ESM101

by Shenzhen Med-Link Electronics Tech Co., Ltd.

Identity

Trade Name
Digital Blood Pressure Monitor EUDAMED
MED-LINK FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Device Name
Digital Blood Pressure Monitor EUDAMED
Model / Reference
ESM101 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06944414031301 EUDAMEDFDA UDI
Basic UDI-DI
B-06944414031301 EUDAMED
510(k) Number
K181154 FDA 510(k)FDA UDI
FDA Product Code
DXN FDA 510(k)FDA UDI
EMDN Code
Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER 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
Germany 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Med-link Wrist and Upper Arm Digital Blood Pressure Monitors are automated, non-invasive devices designed to measure systolic and diastolic blood pressure. Classified under the nomenclature for blood pressure monitors, they provide digital readings for clinical or home use, ensuring accurate assessment of arterial blood pressure in adults.

These devices are intended for single-use or reusable applications, depending on manufacturer guidelines, and are supplied sterile or non-sterile as specified. They are regulated under FDA 510(k) clearance (K181154) and comply with the Medical Device Directive (MDD). The wrist model is worn around the forearm, while the upper arm model encircles the bicep, with both requiring proper sizing for accurate readings. Storage conditions and sterility are detailed in the manufacturer’s instructions.

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 Med-Link Electronics Tech Co., Ltd.

Sources (3)

  • FDA 510(k) K181154 24 fields · synced Oct 6, 2026
  • FDA UDI 51707063-b1cb-46dd-ace3-b6516f281825 33 fields · synced May 29, 2026
  • EUDAMED 6481c81f-ef08-44b4-8462-479e047f7924 61 fields · synced Jul 8, 2026