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Smile - Duo & Smile

by Pleasure Latex Products Sdn. Bhd.

Ref 3638

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 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/MDR Number955501242CG001ZL Basic UDI-DI 09555012421677UDI-DIDate2 Feb 2023RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Condom and Personal Lubricant Packed in a Wallet
Model / Reference
3638
Primary DI / UDI-DI
09555012421677
Basic UDI-DI
955501242CG001ZL
EMDN Code
M9002, U110101
Device Class
Class IIb
Medical Purpose
Not for medical purpose.

Manufacturer details

EUDAMED SRN
MY-PR-000032624

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Properties

Other properties (1)

  • Sterile: No