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Le Capotier XL PRO

by Innolatex Sdn. Bhd. EUDAMED

Active European Union

Ref P56S-T1, P56S, LECAPOTIER-XL-100, LECAPOTIER-XL-144

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-09555163313517 Basic UDI-DIDate28 Oct 2025RegisteredStatusActive
European UnionCE/MDD NumberB-09555163313517 Basic UDI-DIDate28 Oct 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
Le Capotier XL PRO
Le Capotier XL
Device Name
Non-sterile Non-Medicated Natural Rubber Latex Male Condom
Non-sterile Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
P56S-T1, P56S, LECAPOTIER-XL-100, LECAPOTIER-XL-144
Primary DI / UDI-DI
09555163313517, 09555163309985, 09555163311216, 09555163311162
Basic UDI-DI
B-09555163313517, B-09555163309985, B-09555163311216, B-09555163311162, 955516330-NMCM-6F
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
MY-MF-000001246
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Innolatex Sdn. Bhd.

See all devices from Innolatex Sdn. Bhd. →

Properties

Show 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