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Pasante Extra

by Medical-Latex (DUA) Sdn. Bhd. EUDAMED

Active European Union

Ref 1030KAModel P52S-N2, P52S

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060150680809 Basic UDI-DIDate28 Aug 2023RegisteredStatusActive
European UnionCE/MDR NumberB-05060150680809 Basic UDI-DIDate28 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD, CE/MDR Active

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.

Specification

EUDAMED

Trade Name
Pasante Extra
Pasante Extra bulk pack
Device Name
Non-Sterile Non-Medicated Natural Rubber Latex Male Condom
Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
P52S-N2, 1030KA, P52S
Primary DI / UDI-DI
05060150680809, D-PHLEXTBP14464
Basic UDI-DI
B-05060150680809, 88586938-NMCM-V9, B-PHLEXTBP14464
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Spain
Italy
Germany

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