Skip to content

Bergamot SE Latex Powdered Examination Glove

by Bergamot Sdn Bhd 3 variants

Ref Z1255 (XL), Z1254 (L), Z1254 (M), Z1255 (M), Z1255 (S), Z1254 (XS), Z1255 (XS), Z1255 (L)Model Z1 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 Number9555904LPSMS 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  • Withdrawn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
Latex Powdered Examination Glove
Model / Reference
Z1 Series, Z1255 (XL), Z1254 (L), Z1254 (M), Z1255 (M), Z1255 (S), Z1254 (XS), Z1255 (XS), Z1255 (L)
Primary DI / UDI-DI
09555904305986, 09555904304224, 09555904304217, 09555904305962, 09555904305955, 09555904304194, 09555904305948, 09555904305979
Basic UDI-DI
9555904LPSMS
EMDN Code
T010201 Latex 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

Other devices from Bergamot Sdn Bhd

See all devices from Bergamot Sdn Bhd →

Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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