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PROTEX Fruity

by Innolatex (Thailand) Limited

Ref 5064, P53S

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD Number88586938-NMCM-V9 Basic UDI-DIDate4 Sep 2024RegisteredStatusActive
European UnionCE/MDR Number88586938-NMCM-V9 Basic UDI-DIDate4 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
Non-medicated Natural Rubber Latex Male Condoms
Non-Medicated Natural Rubber Latex Male Condom
Model / Reference
5064, P53S
Primary DI / UDI-DI
05708413031028
Basic UDI-DI
88586938-NMCM-V9, B-05708413031028
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
TH-MF-000001249
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Innolatex (Thailand) Limited

See all devices from Innolatex (Thailand) Limited →

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