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Aurelia Distinct

by Maxter Glove Manufacturing Sdn Bhd 5 variants

Ref S

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09555002101411 UDI-DI Date8 Feb 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number955500211637CR Basic UDI-DI 09555002101411UDI-DIDate27 Dec 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Model / Reference
S EUDAMED
29226 GUDID
Primary DI / UDI-DI
09555002101411
Basic UDI-DI
955500211637CR
FDA Product Code
LYY
EMDN Code
T010201 Latex examination / treatment gloves
GMDN Term
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Device Class
Class I
Regulation Number
880.6250
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
S
GUDID
29226

Manufacturer details

EUDAMED SRN
MY-MF-000016719
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Maxter Glove Manufacturing Sdn Bhd

See all devices from Maxter Glove Manufacturing Sdn Bhd →

Properties

  • Single Use
  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No