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BM-Series

by BEYONDMEDI Co., Ltd. EUDAMED

Active European Union

Model BM-055L

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800178000015 Basic UDI-DIDate15 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
Low Temperature Plasma Sterilizer
Model / Reference
BM-055L
Primary DI / UDI-DI
08800178000015
Basic UDI-DI
B-08800178000015
EMDN Code
Z12011309 Plasma sterilisers
Device Class
Class IIb
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
KR-MF-000044027
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BEYONDMEDI Co., Ltd.

Properties

Other properties (11)

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