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Arm Blood Pressure Monitor BPM-A7VL

by Shenzhen IMDK Medical Technology Co., Ltd

510(k) K243118Ref BPM-A7VL

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243118↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06973912940426 UDI-DI Date23 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697391294501BPM5A Basic UDI-DI 06973912940426UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243118 Date26 Nov 2024ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Full name
Arm Blood Pressure Monitor (model: BPM-A7VL)
Trade Name
Arm Blood Pressure Monitor EUDAMED
Imdk GUDID
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
BPM-A7VL
FDA applicant
Shenzhen Imdk Medical Technology Co., Ltd.
Primary DI / UDI-DI
06973912940426
Basic UDI-DI
697391294501BPM5A
Direct Marketing DI
06973912940426
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 870.1130
EU market of registration
Germany
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arm Blood Pressure Monitor BPM-A7VL is a non-invasive blood pressure measurement device designed for upper-arm cuff-based monitoring. It measures systolic and diastolic blood pressure and pulse rate, providing real-time readings for clinical and home use.

This device is supplied as a reusable medical instrument, intended for use in clinical settings, patient homes, or ambulatory care environments. It operates via Bluetooth connectivity for data transmission to compatible devices, adheres to FDA 510(k) and MDR regulatory standards, and requires proper calibration and maintenance as per manufacturer guidelines.

Other devices from Shenzhen IMDK Medical Technology Co., Ltd

See all devices from Shenzhen IMDK Medical Technology Co., Ltd →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is this blood pressure monitor designed for single-use or can it be reused in clinical settings?

    The Arm Blood Pressure Monitor (model BPM-A7VL) is explicitly supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings, patient homes, or ambulatory care environments. Since it is reusable, proper calibration, maintenance, and cleaning protocols as outlined by the manufacturer must be followed to ensure accuracy and hygiene.

  • How does this device transmit its readings, and what kind of compatibility does it offer?

    The BPM-A7VL uses Bluetooth connectivity to send real-time blood pressure and pulse rate measurements to compatible devices. This wireless feature makes it suitable for both clinical monitoring and home use, allowing seamless data transfer to smartphones, tablets, or other electronic health record systems.

  • What regulatory standards does this device meet, and how does that affect its use?

    The device complies with FDA 510(k) clearance and MDR (Medical Device Regulation) standards, confirming its safety, performance, and conformity with global medical device regulations. This means it can be legally used in the U.S. and EU markets, provided it is maintained and calibrated according to manufacturer guidelines.

  • What types of environments is this monitor intended for, and how does that impact its design?

    The BPM-A7VL is designed for clinical settings, patient homes, and ambulatory care, making it versatile for both professional and personal use. Its upper-arm cuff-based design ensures accurate measurements across different environments, while Bluetooth connectivity supports real-time data sharing for better monitoring and patient care.

Properties

  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No