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N65C01-GE010

by Leboo Healthcare Products Limited

Ref N65C01-GE010Model PP Sleeve Cover, Microporous Sleeve Cover, PE Coated Nonwoven Sleeve Cover, PE Sleeve Cover Machine Made, PE Sleeve Cover Hand Made, PVC Sleeve Cover, TPU Sleeve Cover 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L09QP Basic UDI-DI 06974424846503UDI-DIDate8 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  • Withdrawn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 Sleeve Cover, Microporous Sleeve Cover, PE Coated Nonwoven Sleeve Cover, PE Sleeve Cover Machine Made, PE Sleeve Cover Hand Made, PVC Sleeve Cover, TPU Sleeve Cover and other customized specifications, N65C01-GE010
Primary DI / UDI-DI
06974424846503
Basic UDI-DI
697442484L09QP
EMDN Code
T0207 Caps and headwear (excluding personal protective equipment - PPE)
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

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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