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Arm Type Blood Pressure Monitor BPM61 Model 0075N

by AViTA Corporation 12 variants

Ref BPM61Model 0075N

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K242193↗

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK242193 Date22 Oct 2024IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-04710953422083 Basic UDI-DI 04710953422083UDI-DIDate13 Jul 2022RegisteredStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Full name
Arm type Blood Pressure Monitor
Model / Reference
0075N, BPM61
Primary DI / UDI-DI
04710953422083
Basic UDI-DI
B-04710953422083
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000010455
Authorised representative
MDSS GmbH DE-AR-000005430

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.

This device is an Arm Type Blood Pressure Monitor, classified under nomenclature code Z1203020501 as a non-invasive blood pressure measurement instrument. It is designed to measure systolic and diastolic blood pressure and pulse rate in adults via an inflatable cuff placed around the upper arm, providing automated readings for clinical or home monitoring purposes.

The BPM61 Model 0075N is a single-use, non-sterile, non-reusable device intended for use in clinical settings or by trained personnel. It is not implantable or reprocessed, and its UDI (Unique Device Identifier) is B-04710953422083. The device complies with FDA 510K, MDD, and MDR regulations and is classified as Class IIa under EU medical device legislation. Storage and handling follow standard non-sterile medical device protocols.

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Properties

  • Administering Medicine
  • Measuring Function

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No