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N61A03

by Leboo Healthcare Products Limited China EUDAMED

Ref N61A03Model PP Isolation Gown, PE Coated Isolation Gown, N61P01, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button,etc

EMDN T0299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L03QB Basic UDI-DIDate5 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PP Isolation Gown, PE Coated Isolation Gown, N61P01, Half PE Coated Isolation Gown, SMS Isolation Gown, Surgical Isolation Gown, Patient Gown With Short Sleeve, Patient Gown Without Sleeve, Lab Coat With Velcro, Lab Coat With Press Button, etc, N61A03
Primary DI / UDI-DI
06974424843229
Basic UDI-DI
697442484L03QB
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008521
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Leboo Healthcare Products Limited

See all devices from Leboo Healthcare Products Limited →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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 06974424843229|697442484L03QB 61 fields · synced 24 Oct 2026