CU Controller Unit

Model / Reference

CU, +B271CU0

Primary DI / UDI-DI

+B271CU0

Basic UDI-DI

B-+B271CU0

EMDN Code

Z120614 Infrared ultraviolet ray lamps

Device Class

Class IIa

Market of Registration

Northern Ireland

EUDAMED SRN

CA-MF-000011432

Authorised representative

Obelis s.a. BE-AR-000000106

• Duo+ 240

  Class IIa

  CE/MDD

• LD-I 75 and LD-I 200

  Class II

  CE/MDD FDA 510(k) K072551 Active Cleared 2 Apr 2008

• Bioflex Prescription System and Related Treatment Heads

  Class II

  FDA 510(k) K051875 Active Cleared 13 Mar 2006

• Bioflex LD-R100 Treatment Head

  Class II

  CE/MDD FDA 510(k) K081355 Active Cleared 18 Dec 2008

• Bioflex Professional Therapy System

  Class II

  FDA 510(k) K023621 Active Cleared 10 Apr 2003

• Bioflex Ld-175 and Ld-1200 Treatment Heads

  Class II

  FDA 510(k) K041885 Active Cleared 24 Feb 2005

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