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Operion 349 Ultra Dual View

EUDAMED

Class I (EU MDR)

Ref OP-349.4-HTModel Wall System Monitor

by Rein medical GmbH

Identity

Trade Name
OPERION 349 ULTRA DUAL VIEW EUDAMED
Device Name
WS49DV.1 EUDAMED
Model / Reference
Wall System Monitor EUDAMED
OP-349.4-HT EUDAMED

Identifiers

Primary DI / UDI-DI
04061631011229 EUDAMED
Basic UDI-DI
406163100000WS49DV1QP EUDAMED
Direct Marketing DI
04061631011229 EUDAMED
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

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

Category: Device sterilization/disinfection container, reusable

Operion 349 Ultra Dual View by Rein medical GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Rein medical GmbH
EUDAMED SRN
DE-MF-000018721

Sources (1)

  • EUDAMED 5b638a47-daa0-4186-9153-3ce31d8255ea 61 fields · synced Jun 18, 2026