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Nitrile gloves

by Gracemed Medical Technology(Wuhan) Co., Ltd. EUDAMED

Active European Union

Ref GMNGBC001 (BLUE COLOR) (XS)Model GMNGBC001(BLUE COLOR)；XS, S, M, L, XL GMNGVC001(VIOLET)； XS, S, M, L, XL GMNGBLAC001(Black color)； XS, S, M, L, XL GMNGBLBC001(Black Blue color)； XS, S, M, L, XL GMNGPC001(PURPLE)； XS, S, M, L, XL GMNGCBC001(COBALT BLUE)； XS, S, M, L, etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697781267Nitrilegloves3A Basic UDI-DIDate2 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Nitrile gloves
Model / Reference
GMNGBC001(BLUE COLOR)；XS, S, M, L, XL GMNGVC001(VIOLET)； XS, XL GMNGBLAC001(Black color)； XS, XL GMNGBLBC001(Black Blue color)； XS, XL GMNGPC001(PURPLE)； XS, XL GMNGCBC001(COBALT BLUE)； XS, etc, GMNGBC001 (BLUE COLOR) (XS)
Primary DI / UDI-DI
06977812670506
Basic UDI-DI
697781267Nitrilegloves3A
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000043943
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Gracemed Medical Technology(Wuhan) Co., Ltd.

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