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Surgical Mobile C-Arm Imaging System Opescope Acteno
EUDAMEDClass IIb (EU MDR)
Ref 566-28800-83Model 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 EUDAMED566-28800-83 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217068739 EUDAMED
- Basic UDI-DI
- 45402170100000000000015SX EUDAMEDB-04540217068739 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 b0409ee4-f15e-443c-a520-f68911c7b23a 61 fields · synced Jun 18, 2026
- EUDAMED a2a8b6c1-3268-4641-93b3-84b3e7e87ab3 61 fields · synced May 19, 2026