← Back to catalogue
Opescope Acteno
EUDAMEDClass IIb (EU MDR)
Ref 566-24400-11Ref 566-24400-51Ref 566-24400-14Ref 566-24400-53
Identity
- Trade Name
- OPESCOPE ACTENO EUDAMED
- Device Name
- SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO EUDAMED
- Model / Reference
- 566-24400-11 EUDAMED566-24400-51 EUDAMED566-24400-14 EUDAMED566-24400-53 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04540217061662 EUDAMED04540217064076 EUDAMED04540217061709 EUDAMED04540217064083 EUDAMED
- Basic UDI-DI
- B-04540217061662 EUDAMEDB-04540217064076 EUDAMEDB-04540217061709 EUDAMEDB-04540217064083 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Opescope Acteno by Shimadzu Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04540217061662 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shimadzu Corporation
- EUDAMED SRN
- JP-MF-000025145
- Authorised Representative
- Shimadzu Europa GmbH DE-AR-000013563
Sources (4)
- EUDAMED a7c4f2da-3db2-4f1e-bc82-51191f6ad505 61 fields · synced Sep 18, 2026
- EUDAMED 05c8f452-c02e-47fa-af06-f2e0c1ffd565 61 fields · synced May 17, 2026
- EUDAMED c4677d2f-73b0-4a72-b7b2-81090dcee35d 61 fields · synced May 18, 2026
- EUDAMED 25268a6e-5945-435e-ba65-600356be8daf 61 fields · synced May 18, 2026