Amnicot

Model / Reference

ACD01-P

Primary DI / UDI-DI

09350902001966

Basic UDI-DI

B-09350902001966

EMDN Code

U1005 Amniotic membrane perforators

Device Class

Class IIa

Market of Registration

Poland

EUDAMED SRN

AU-MF-000018687

Authorised representative

Advena Limited MT-AR-000000234

• V Set

  Class II

  FDA 510(k) K900336 Active Cleared 4 Oct 1990

• Single Lumen O'neil Aspiration & Irrigation Needle

  Class I

  FDA 510(k) K895594 Active Cleared 6 Oct 1989

• Obstetric Cup (Modification)

  Class II

  FDA 510(k) K891465 Active Cleared 11 May 1989

• Modified Urinary Catheter Introducer (Uci)

  Class II

  FDA 510(k) K890400 Active Cleared 12 Sep 1989

• O'Neil Sterile Field Urinary Catheter Kit With Prep Pads

  Class II

  FDA 510(k) K011055 Active Cleared 6 Jun 2001

• Aspirating and Irrigating Cysts Needles

  Class I

  FDA 510(k) K885283 Active Cleared 22 Mar 1989

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