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Onsize 69

EUDAMED

Class IIb (EU MDR)

Ref QA-224

by Richter Rubber Technology Sdn Bhd

Identity

Trade Name
Onsize 69 EUDAMED
Device Name
Non-Medicated Natural Latex Condoms EUDAMED
Model / Reference
QA-224 EUDAMED

Identifiers

Primary DI / UDI-DI
09556807402147 EUDAMED
Basic UDI-DI
9556807CD001UF EUDAMED
Direct Marketing DI
09556807402147 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

Onsize 69 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

EUDAMED SRN
MY-MF-000023324
Authorised Representative
rrt Vertrieb und Service GmbH DE-AR-000021443

Sources (1)

  • EUDAMED 5f50d27e-a489-4b2a-ad82-7edb7b93aa77 61 fields · synced Jun 18, 2026