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Finessis Aegis

by Sentienx Sdn. Bhd. Malaysia EUDAMED

Ref FZA-100594042, FZA-100594041, FZA-100594044, FZA-100594045, FZA-100594046, FZA-100594047 EMDN T010199

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09551005940422 Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Sterile Flexylon (Aegis) Surgical Polymer Powder Free Gloves
Model / Reference
FZA-100594042, FZA-100594041, FZA-100594044, FZA-100594045, FZA-100594046, FZA-100594047
Primary DI / UDI-DI
09551005940422, 09551005940415, 09551005940446, 09551005940453, 09551005940460, 09551005940477
Basic UDI-DI
B-09551005940422, B-09551005940415, B-09551005940446, B-09551005940453, B-09551005940460, B-09551005940477
EMDN Code
T010199 Surgical gloves - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000023461
Authorised representative
Ulma International GmbH DE-AR-000010015

Other devices from Sentienx Sdn. Bhd.

See all devices from Sentienx Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (6)

  • EUDAMED 3eeb437d-a7cb-4048-bf5a-253361b6542c 61 fields · synced 22 Oct 2026
  • EUDAMED 09551005940415|B-09551005940415 61 fields · synced 18 May 2026
  • EUDAMED 09551005940446|B-09551005940446 61 fields · synced 9 Jul 2026
  • EUDAMED 09551005940453|B-09551005940453 61 fields · synced 18 Jul 2026
  • EUDAMED 09551005940460|B-09551005940460 61 fields · synced 20 Jul 2026
  • EUDAMED 09551005940477|B-09551005940477 61 fields · synced 1 Aug 2026