Radiaxon Pi Sensitive

Device Name

Polyisoprene Radiation Attenuating Surgical Glove Powder Free, Sterile.

Model / Reference

R3565-86

Primary DI / UDI-DI

09557795008274

Basic UDI-DI

9557795RPG-SG02KV

EMDN Code

T01010203 Polyisopren surgical gloves

Device Class

Class IIa

Market of Registration

Austria

EUDAMED SRN

MY-MF-000004690

Authorised representative

REMESCO HANDELSGESMBH AT-AR-000002669

• Comfit Powder Free

  Class IIa

  CE/MDR

• Powder Free Latex Examination Glove, Non-Sterile

  Class I

  FDA 510(k) K211601 Active Cleared 22 Aug 2022

• Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant

  Class I

  FDA 510(k) K210330 Active Cleared 4 Mar 2022

• Profeel Powder Free

  Class IIa

  CE/MDR

• Dermagrip Black Nitrile

  Class I

  CE/MDR

• Dermagrip Sterile

  Class I

  CE/MDR

See all devices from WRP Asia Pacific Sdn. Bhd. →