Skip to content

PP Isolation Gown (with elastic)

by Vandl Biotechnology Inc China EUDAMED

Ref YL-60014 EMDN T0205

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G546008938 Basic UDI-DIDate26 Sep 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  • Withdrawn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 24 Oct 2026

Trade Name
PP Isolation Gown (with elastic)
Vandl Isolation Gown with Elastic
Device Name
isolation gown
Model / Reference
YL-60014
Primary DI / UDI-DI
+G546VANDL0089AY0;, +G546YL600141
Basic UDI-DI
++G546008938
Unit of Use DI
+G546YL600140
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000037509
Authorised representative
MB Global Service B.V. NL-AR-000037296

Other devices from Vandl Biotechnology Inc

See all devices from Vandl Biotechnology Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: 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 (2)

  • EUDAMED 912238dd-07b3-475e-a067-153b2ea503da 61 fields · synced 23 Oct 2026
  • EUDAMED +G546YL600141|++G546008938 61 fields · synced 24 Oct 2026