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N65B04-OS02FC-B01

by Leboo Healthcare Products Limited

Ref N65B04-OS02FC-B01, N65B04Model HDPE Glove Blocked, HDPE Glove With Paper Header, HDPE Glove Box-Packed, HDPE Glove Bag-Packed, LDPE Glove Blocked, LDPE Glove With Paper Header, LDPE Glove Box-Packed, LDPE Glove Bag-Packed, TPE Glove, LDPE Glove with Long Sleeve, PVC Glove, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697442484L07QK Basic UDI-DI Date8 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  • Withdrawn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
HDPE Glove Blocked, HDPE Glove With Paper Header, HDPE Glove Box-Packed, HDPE Glove Bag-Packed, LDPE Glove Blocked, LDPE Glove With Paper Header, LDPE Glove Box-Packed, LDPE Glove Bag-Packed, TPE Glove, LDPE Glove with Long Sleeve, PVC Glove, etc, N65B04-OS02FC-B01, N65B04
Primary DI / UDI-DI
06974424841669, 06974424847876, 06974424844981
Basic UDI-DI
697442484L07QK
EMDN Code
T010299 Examination / treatment gloves - 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

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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