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One Touch - Enjoymaxx

by Thai Nippon Rubber Industry Public Company Limited 2 variants

Ref FORANS-036, FORANS-034

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181844↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88529610TNRC01YQ Basic UDI-DI Date27 Nov 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK181844 Date15 Apr 2019IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Natural Rubber Latex Non-Medicated Male Condom
Model / Reference
FORANS-036, FORANS-034
Primary DI / UDI-DI
08852961023855, 38852961023832
Basic UDI-DI
88529610TNRC01YQ
Direct Marketing DI
08852961023855
38852961023832
EMDN Code
U110101 Condoms
Device Class
Class IIb
EU market of registration
Latvia

Manufacturer details

EUDAMED SRN
TH-MF-000012641
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Thai Nippon Rubber Industry Public Company Limited

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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