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Surgical Mobile C-Arm Imaging System Opescope Acteno
EUDAMEDClass IIb (EU MDR)
Ref 566-28800-61Model SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO
Identity
- Trade Name
- SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMEDOPESCOPE ACTENO EUDAMED
- Model / Reference
- SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED566-28800-61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217068708 EUDAMED
- Basic UDI-DI
- 45402170100000000000015SX EUDAMEDB-04540217068708 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 45402170100000000000015SX | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 45402170100000000000015SX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (2)
- EUDAMED f943d3a9-1a0e-4a15-a8a9-4d357ffd73f3 61 fields · synced Jul 11, 2026
- EUDAMED 3a45c28c-edb7-4978-8fd2-fe878ff1d4a7 61 fields · synced May 17, 2026