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N61E01-GH028

by Leboo Healthcare Products Limited

Ref N61E01-GH028Model Scrub Shirt, Scrub Shirt Lite, Warm Up Jacket, Scrub Suit, Scrub Suit Lite, Warm Up Jacket Suit, N61E02，N61D04 and other customized specifications

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 Number697442484L20QB Basic UDI-DI 06974424843717UDI-DIDate6 Dec 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  • Withdrawn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
Scrub Shirt, Scrub Shirt Lite, Warm Up Jacket, Scrub Suit, Scrub Suit Lite, Warm Up Jacket Suit, N61E02，N61D04 and other customized specifications, N61E01-GH028
Primary DI / UDI-DI
06974424843717
Basic UDI-DI
697442484L20QB
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU 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

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