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ON) Clinic

EUDAMED

Class IIa (EU MDR)

Ref QA-280

by Richter Rubber Technology Sdn Bhd

Identity

Trade Name
ON) Clinic EUDAMED
Device Name
Non Sterile Natural Latex Probe Cover EUDAMED
Model / Reference
QA-280 EUDAMED

Identifiers

Primary DI / UDI-DI
09556807401591 EUDAMED
Basic UDI-DI
9556807PC001YP EUDAMED
Direct Marketing DI
09556807401591 EUDAMED
EMDN Code
Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED

Classification

Device Class
Class IIa 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

ON) Clinic by Richter Rubber Technology Sdn. Bhd. — Class IIa — 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 8a9f0b21-2270-42c9-a11a-81d9c686ac32 61 fields · synced Jun 19, 2026