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Lightweight Black Nitrile Gloves M

by Ccir Asia Pacific Limited EUDAMED

Active European Union

Ref CCIR-007112

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489712016CCIR-007105R Basic UDI-DIDate25 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Black nitrile examination gloves, Powder free
Model / Reference
CCIR-007112
Primary DI / UDI-DI
14897120160324
Basic UDI-DI
489712016CCIR-007105R
Unit of Use DI
04897120167326
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
HK-MF-000003035
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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