Skip to content

Suction Irrigation Set

by Advanced Medical Design Co., Ltd. FDA registration: Taiwan EUDAMED

Ref SI0009Model ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0 EMDN A03040299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471160599ASI016Q Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0, SI0009
Primary DI / UDI-DI
04711605995429
Basic UDI-DI
471160599ASI016Q
EMDN Code
A03040299 Irrigation kits, single-use - other
Device Class
Class IIa
Market of Registration
Croatia

Manufacturer details

EUDAMED SRN
TW-MF-000019772
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Advanced Medical Design Co., Ltd.

See all devices from Advanced Medical Design Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 45a02d53-da41-47c8-82cb-a9b4e5dcdce6 61 fields · synced 25 Oct 2026