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SOFT Classic Natural

by Karex Industries Sdn. Bhd. 2 variants

Ref P53S, C1530DBEVF (Tutti Frutti), C1530DBEVF (Aloe Vera), CS-018-11-PC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-03385830604831 Basic UDI-DI Date5 Sep 2023RegisteredStatusActive
European UnionCE/MDD NumberB-03385830604831 Basic UDI-DI Date5 Sep 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  • Withdrawn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

Trade Name
SOFT Classic Natural
Soft
Device Name
Non-sterile Non-medicated Natural Rubber Latex Male Condom
Non-sterile Regular Plain Water-based Lubricant
Non-sterile Synthetic Polyisoprene Latex Protective Transducer Covers
Model / Reference
P53S, C1530DBEVF (Tutti Frutti), C1530DBEVF (Aloe Vera), CS-018-11-PC
Primary DI / UDI-DI
03385830604831, 09556564088578, 09556564087922, 09556564087939, 09556564088301, 09556564088561
Basic UDI-DI
B-03385830604831, B-09556564088578, B-09556564087922, B-09556564087939, 9556564-NSPIPC-83, B-09556564088561
EMDN Code
U110101, V9099, Z11040185
Device Class
Class IIb
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
MY-MF-000001247
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Karex Industries Sdn. Bhd.

See all devices from Karex Industries Sdn. Bhd. →

Properties

  • Contains Latex YesEUDAMEDNoEUDAMED

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