Skip to content

BM3/BM3 Plus

by Bionet Co., Ltd.

BM3/BM3 Plus is a medical device (FDA Class II; FDA product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)) made by Bionet Co., Ltd., cleared under FDA 510(k) K132033 on 4 Dec 2013 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943644), active as of 12 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K132033

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809276943644 UDI-DI Date15 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132033 Date4 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132033 decided 4 Dec 2013 Active
  • FDA GUDID UDI-DI 08809276943644 listed 15 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132033
  2. Listed FDA GUDID 08809276943644

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Invasive-detection multi-parameter physiological monitor, reusable
Model / reference
BM3/BM3 Plus
Primary DI / UDI-DI
08809276943644
510(k) Number
FDA product code
MWI
GMDN term
Invasive-detection multi-parameter physiological monitor, reusable
Device class
Class II
Regulation number
870.2300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Invasive-detection multi-parameter physiological monitor, reusable

Similar devices

Other devices filed under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Other devices from Bionet Co., Ltd.

See all devices from Bionet Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)