Medical Device Division · registration 160134Active

MEDRAD Avanta Fluid Management Injection System (AVA 500 PEDL, AVA 500 TABL, AVA 500 SPAT L, AVA 500 MPAT, AVA 500 SPAT ANGlO, AVA 500 HC)

Name: MEDRAD Avanta Fluid Management Injection System (AVA 500 PEDL, AVA 500 TABL, AVA 500 SPAT L, AVA 500 MPAT, AVA 500 SPAT ANGlO, AVA 500 HC) — Medical Device Division 160134
Creator: Bayer Medical Care Inc.
Keywords: MEDRAD Avanta Fluid Management Injection System (AVA 500 PEDL, AVA 500 TABL, AVA 500 SPAT L, AVA 500 MPAT, AVA 500 SPAT ANGlO, AVA 500 HC), MEDRAD Avanta Fluid Management Injection System (AVA 500 PEDL, AVA 500 TABL, AVA 500 SPAT L, AVA 500 MPAT, AVA 500 SPAT ANGlO, AVA 500 HC), 160134, Injectors, Contrast Media, Medical Device Division

Hong KongInjectors, Contrast MediaClass IIIBayer Medical Care Inc.

Verified

Official record identity

MDACS listing number: 160134
Model name: MEDRAD Avanta Fluid Management Injection System (AVA 500 PEDL, AVA 500 TABL, AVA 500 SPAT L, AVA 500 MPAT, AVA 500 SPAT ANGlO, AVA 500 HC)
Registration date: July 23, 2025
Expiry date: May 24, 2031
Source update date: September 17, 2025
Status: Active

Classification

Risk class: Class III
Published category: Injectors, Contrast Media

Published parties

Registrant / registration holder: Prism Technologies Limited
Manufacturer: Bayer Medical Care Inc.

Official description

Injectors, Contrast Media

Additional source fields

AMD nomenclature code: 17968
Traditional Chinese local responsible person: 稜科有限公司
Local responsible person phone: 27863233
Published manufacturer address: 1 Bayer Drive, Indianola, Pennsylvania 15051-0780 USA
Revision number: d

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.