Skip to content

Pasante Regular

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

Active European Union

Ref T54BH-N4, 1010KA RD, 1010K, 1010KA, R1201T / R1201K-ME, R1529K, 1011KAModel T54BH

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05060150680229 Basic UDI-DIDate16 Aug 2023RegisteredStatusActive
European UnionCE/MDR NumberB-05060150680229 Basic UDI-DIDate16 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  • Withdrawn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 Regular
Pasante Regular bulk pack
Device Name
Non-Sterile Non-Medicated Natural Rubber Latex Male Condom
Non-sterile Non-medicated Natural Rubber Latex Male Condoms.
Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
T54BH-N4, 1010KA RD, 1010K, 1010KA, R1201T / R1201K-ME, R1529K, T54BH, 1011KA
Primary DI / UDI-DI
05060150680229, 05060493186860, 05032331008160, 05032331014895, 05032331006647, 08858693803420, 05060150680663, D-PHLREGBP144WC
Basic UDI-DI
B-05060150680229, 955545180-NMCM-9Y, B-05032331008160, B-05032331014895, B-05032331006647, 88586938-NMCM-V9, B-05060150680663, B-PHLREGBP144WC
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Ireland
Poland
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