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Surgical Mobile C-Arm Imaging System Opescope Acteno

EUDAMED

Class IIb (EU MDR)

Ref 566-24400-27Model SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO

by Shimadzu Corporation

Identity

Trade Name
SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
OPESCOPE ACTENO EUDAMED
Device Name
SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
Model / Reference
SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
566-24400-27 EUDAMED

Identifiers

Primary DI / UDI-DI
04540217065165 EUDAMED
Basic UDI-DI
45402170100000000000015SX EUDAMED
B-04540217065165 EUDAMED
EMDN Code
Z11030780 REMOTE CONTROL TABLES - HARDWARE ACCESSORIES 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

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

Surgical Mobile C-Arm Imaging System Opescope Acteno by Shimadzu Corporation — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shimadzu Corporation
EUDAMED SRN
JP-MF-000025145
Authorised Representative
Shimadzu Europa GmbH DE-AR-000013563

Sources (2)

  • EUDAMED 97f515ae-3731-47ef-949f-2d8ef673dc67 61 fields · synced Jul 25, 2026
  • EUDAMED aaf0a154-c47d-45be-807f-81bf55bc1674 61 fields · synced May 19, 2026