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N61A04

by Leboo Healthcare Products Limited

Ref N61A04Model 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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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, N61A04
Primary DI / UDI-DI
06974424844639, 06974424844691
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

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Properties

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