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Medical device - Software

by Bionet Co., Ltd.

Ref BM Central Pro

Medical device - Software (BM Central Pro) is a Class IIb device made by Bionet Co., Ltd., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 880927694BMCTJ) with CE/MDR certificate 2024-MDR/QS-021 valid until 2 Apr 2029, active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

2 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880927694BMCTJ Basic UDI-DI 08809276944047UDI-DIDate26 May 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2024-MDR/QS-021 Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    27 Nov 2025
    Expires
    2 Apr 2029
    Reason
    Other

Timeline

3 dated events

  1. Certificate issued EUDAMED 2024-MDR/QS-021
  2. Registered EUDAMED 880927694BMCTJ
  3. Certificate expires EUDAMED 2024-MDR/QS-021

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Medical device - Software
Model / reference
BM Central Pro
Primary DI / UDI-DI
08809276944047
Basic UDI-DI
880927694BMCTJ
Direct marketing DI
08809276944047
EMDN code
Z1203020292 Multi-parameter monitors - medical device software
Device class
Class IIb
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000013439
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Other properties (14, all answered No)