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Elite Insufflation Filter/Tubing Set with O Ring Connector

by Advanced Medical Design Co., Ltd. EUDAMED

Active European Union

Ref PS3601EModel AIF-400Z, AIF-403Z, AIF-430Z, AIF-4400, AIF-460Z, AIF-4700, AIF-500Z, AIF-530Z, AIF-540Z, AIF-560Z, AIF-600Z, AIF-630Z, AIF-640Z, AIF-660Z, AIF-670Z

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471160599AIF0143 Basic UDI-DIDate10 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Insufflation Filter with Tubing Set
Model / Reference
AIF-400Z, AIF-403Z, AIF-430Z, AIF-4400, AIF-460Z, AIF-4700, AIF-500Z, AIF-530Z, AIF-540Z, AIF-560Z, AIF-600Z, AIF-630Z, AIF-640Z, AIF-660Z, AIF-670Z, PS3601E
Primary DI / UDI-DI
05051223038436
Basic UDI-DI
471160599AIF0143
EMDN Code
R040199 Ventilation filters - other
Device Class
Class IIa
Market of Registration
Northern Ireland

Manufacturer details

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

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Properties

Show properties
  • 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