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Glyde Pro Maxi

by Richter Rubber Technology Sdn. Bhd. EUDAMEDGUDID

Active European Union and United States

Ref QA-224

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMY26/00000108 Date6 Feb 2026IssuedStatusActive expires 6 Feb 2031
United StatesGUDID listing GUDID Number19556807570843 UDI-DIDate2 Dec 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MY26/00000108 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    6 Feb 2026
    Expires
    6 Feb 2031

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Glyde Pro Maxi EUDAMED
Glyde GUDID
Generic Name
Basic male condom, Hevea-latex
Device Name
Non-Medicated Natural Latex Condoms
Model / Ref / Catalog
QA-224, Pro Maxi
Primary DI / UDI-DI
19556807570843
Basic UDI-DI
9556807CD001UF
Direct Marketing DI
19556807570843
510(k) Number
FDA Product Code
HIS
EMDN Code
U110101 Condoms
GMDN Term
Basic male condom, Hevea-latex
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
884.5300
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
QA-224
GUDID
Pro Maxi
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K070511)

Show all (12)

Other devices from Richter Rubber Technology Sdn. Bhd.

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Properties

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

Other properties (18)

  • 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
  • Manufacturing Date: No