Skip to content

AAMedix

by Aamedix Glove Sdn Bhd 2 variants

Ref AA 11146-LTX-PModel Latex Powdered Examination Gloves

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9551015251114-PEU Basic UDI-DI 00723860111463UDI-DIDate8 Mar 2023RegisteredStatusActive

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  • Withdrawn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
AAMedix Latex Powdered Examination Gloves
Model / Reference
Latex Powdered Examination Gloves, AA 11146-LTX-P
Primary DI / UDI-DI
00723860111463
Basic UDI-DI
9551015251114-PEU
Direct Marketing DI
00723860111463
EMDN Code
T010201 Latex examination / treatment gloves
Device Class
Class I
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
MY-MF-000025086
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Aamedix Glove Sdn Bhd

See all devices from Aamedix Glove Sdn Bhd →

Properties

  • Contains Latex
  • Reprocessed
  • Administering Medicine

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No