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Vitalis Premium Comfort Plus

EUDAMED

Class IIb (EU MDR)

Ref QA-224

by Richter Rubber Technology Sdn Bhd

Identity

Trade Name
Vitalis Premium Comfort Plus EUDAMED
Device Name
Non-Medicated Natural Latex Condoms EUDAMED
Model / Reference
QA-224 EUDAMED

Identifiers

Primary DI / UDI-DI
29556807432742 EUDAMED
29556807482891 EUDAMED
29556807472984 EUDAMED
09556807452913 EUDAMED
09556807452760 EUDAMED
Basic UDI-DI
9556807CD001UF EUDAMED
Direct Marketing DI
29556807432742 EUDAMED
29556807482891 EUDAMED
29556807472984 EUDAMED
09556807452913 EUDAMED
09556807452760 EUDAMED
EMDN Code
U110101 CONDOMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Vitalis Premium Comfort Plus by Richter Rubber Technology Sdn. Bhd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Richter Rubber Technology Sdn Bhd
EUDAMED SRN
MY-MF-000023324
Authorised Representative
rrt Vertrieb und Service GmbH DE-AR-000021443

Sources (5)

  • EUDAMED 142af502-f5f4-4e03-98dc-19e8efa6c31c 61 fields · synced Sep 18, 2026
  • EUDAMED a9cd6240-9ad2-482c-9a9c-924c1ecd882f 61 fields · synced May 17, 2026
  • EUDAMED 4f154c06-6548-40a2-b016-5d43b7b6ff10 61 fields · synced May 17, 2026
  • EUDAMED d2d8c91f-b389-4977-bb0f-75a2bdabc39b 61 fields · synced May 17, 2026
  • EUDAMED 3a218724-4641-4435-bbf6-95dad2154e7c 61 fields · synced May 19, 2026