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Bergamot SE Nitrile Powder Free Examination Glove

by Bergamot Sdn Bhd 4 variants

Ref X2235 (XXL), X2235 (L), X2235 (XS), X2238 (XS), X2235 (S), X2238 (XL), X2238 (L), X2238 (S)Model X Series

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 Number9555904NPFMA Basic UDI-DI Date19 Nov 2021RegisteredStatusActive

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  • Withdrawn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

Device Name
Nitrile Powder Free Examination Glove
Model / Reference
X Series, X2235 (XXL), X2235 (L), X2235 (XS), X2238 (XS), X2235 (S), X2238 (XL), X2238 (L), X2238 (S)
Primary DI / UDI-DI
09555904305832, 09555904303067, 09555904303036, 09555904303890, 09555904303043, 09555904303937, 09555904303920, 09555904303906
Basic UDI-DI
9555904NPFMA
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000004005
Authorised representative
ASAP Innovations Ltd. IE-AR-000002548

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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