Skip to content

Continuum

by Thai Nippon Rubber Industry Public Company Limited 2 variants

Ref CTNSCO-001

Active European Union

CE MDR

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

Overview

The ContINUUM device is a medical device designed for the management of male infertility, particularly in cases where natural rubber latex (NR-L) has been identified as a potential allergen or irritant. The device features a unique design and materials that aim to minimize the risk of adverse reactions.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88529610TNRC01YQ Basic UDI-DI 08852961024937UDI-DIDate27 Nov 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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Natural Rubber Latex Non-Medicated Male Condom
Model / Reference
CTNSCO-001
Primary DI / UDI-DI
08852961024937
Basic UDI-DI
88529610TNRC01YQ
Direct Marketing DI
08852961024937
EMDN Code
U110101 Condoms
Device Class
Class IIb
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
TH-MF-000012641
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Thai Nippon Rubber Industry Public Company Limited

See all devices from Thai Nippon Rubber Industry Public Company Limited →

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