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Pasante Tropical

by Medical-Latex (DUA) Sdn. Bhd. 3 variants

Ref 1075KModel P53S-N1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05060150680267 Basic UDI-DI 05060150680267UDI-DIDate29 Aug 2023RegisteredStatusActive
European UnionCE/MDD NumberB-05060150680267 Basic UDI-DI 05060150680267UDI-DIDate29 Aug 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  • Withdrawn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, CE/MDD Active

Specification

EUDAMED

Device Name
Non-Sterile Non-Medicated Natural Rubber Latex Male Condom
Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
P53S-N1, 1075K
Primary DI / UDI-DI
05060150680267
Basic UDI-DI
B-05060150680267, 88586938-NMCM-V9
EMDN Code
U110101 Condoms
Device Class
Class IIb
EU market of registration
Spain
Italy

Manufacturer details

EUDAMED SRN
MY-MF-000001244
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Medical-Latex (DUA) Sdn. Bhd.

See all devices from Medical-Latex (DUA) Sdn. Bhd. →

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